Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-30 @ 8:20 PM
Study NCT ID:
NCT00909857
Status:
COMPLETED
Last Update Posted:
2015-08-24
First Post:
2009-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect on Primary Dysmenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Venezuela']}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'C023635', 'term': 'dienogest'}, {'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'D016912', 'term': 'Levonorgestrel'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'id': 'D009644', 'term': 'Norgestrel'}, {'id': 'D009652', 'term': 'Norpregnenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles', 'otherNumAtRisk': 234, 'otherNumAffected': 131, 'seriousNumAtRisk': 234, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles', 'otherNumAtRisk': 230, 'otherNumAffected': 122, 'seriousNumAtRisk': 230, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 55, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 55, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 40, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 43, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dysfunctional uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 208, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 210, 'numAffected': 82}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 28, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cervix inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Helminthic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Ovarian torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.6', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.6', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '-10.0', 'spread': '8.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.0', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period).', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.2', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '12.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).', 'unitOfMeasure': 'Tablets', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.5', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '14.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).', 'unitOfMeasure': 'Tablets', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'title': 'Baseline period-daily activities impaired', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}, {'value': '91.3', 'groupId': 'OG001'}]}]}, {'title': 'Baseline period- leisure activities impaired', 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000'}, {'value': '89.6', 'groupId': 'OG001'}]}]}, {'title': 'Treatment period-daily activities impaired', 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000'}, {'value': '56.5', 'groupId': 'OG001'}]}]}, {'title': 'Treatment period- leisure activities impaired', 'categories': [{'measurements': [{'value': '47.9', 'groupId': 'OG000'}, {'value': '56.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'title': 'Baseline period-daily activities impaired', 'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000'}, {'value': '92.2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline period- leisure activities impaired', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}, {'value': '90.0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment period-daily activities impaired', 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment period- leisure activities impaired', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000'}, {'value': '61.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Satisfied With Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000'}, {'value': '50.4', 'groupId': 'OG001'}]}]}, {'title': 'Saatisfied', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From cycle 1 to cycle 3 (28 days per cycle)', 'description': 'Participants were asked to express the degree of their satisfaction with study treatment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Number of Days With Bleeding or Spotting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '23.6', 'spread': '9.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Number of Episodes With Bleeding or Spotting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.", 'unitOfMeasure': 'Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Mean Length of Bleeding or Spotting Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '5.17', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '5.83', 'spread': '2.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Maximum Length of Bleeding or Spotting Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '5.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '5.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Number of Days With Spotting-only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Number of Episodes With Spotting-only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.", 'unitOfMeasure': 'Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Mean Length of Spotting Only Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '3.29', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '3.26', 'spread': '2.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Maximum Length of Spotting Only Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Difference in Duration Between Longest and Shortest Spotting Only Episode', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.", 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Withdrawal Bleeding at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '91.2', 'groupId': 'OG000'}, {'value': '93.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Withdrawal Bleeding at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000'}, {'value': '79.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Length of Withdrawal Bleeding Episodes at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Length of Withdrawal Bleeding Episodes at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Onset of Withdrawal Bleeding Episodes at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '5.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Onset of Withdrawal Bleeding Episodes at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Intracyclic Bleeding at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Intracyclic Bleeding at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '11.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Number of Intracyclic Bleeding Episodes at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.', 'unitOfMeasure': 'Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Number of Intracyclic Bleeding Episodes at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.', 'unitOfMeasure': 'Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Maximum Length of Intracyclic Bleeding Episodes at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Maximum Length of Intracyclic Bleeding Episodes at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Number of Intracyclic Bleeding Days at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Number of Intracyclic Bleeding Days at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'title': 'Spotting', 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000'}, {'value': '62.2', 'groupId': 'OG001'}]}]}, {'title': 'Light', 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}, {'value': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'Normal', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '13.5', 'groupId': 'OG001'}]}]}, {'title': 'Heavy', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}, {'value': '13.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'title': 'Spotting', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}]}]}, {'title': 'Light', 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}]}]}, {'title': 'Normal', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}]}]}, {'title': 'Heavy', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000'}, {'value': '40.4', 'groupId': 'OG001'}]}]}, {'title': '4 working hours', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}]}]}, {'title': '1 working day', 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000'}, {'value': '29.6', 'groupId': 'OG001'}]}]}, {'title': '>= 2 working days', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '13.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening (28 days)', 'description': 'The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '47.9', 'groupId': 'OG000'}, {'value': '51.7', 'groupId': 'OG001'}]}]}, {'title': '4 working hours', 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000'}, {'value': '11.7', 'groupId': 'OG001'}]}]}, {'title': '1 working day', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000'}, {'value': '23.9', 'groupId': 'OG001'}]}]}, {'title': '>= 2 working days', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline (28 days per cycle)', 'description': 'The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000'}, {'value': '72.6', 'groupId': 'OG001'}]}]}, {'title': '4 working hours', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}]}]}, {'title': '1 working day', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '8.7', 'groupId': 'OG001'}]}]}, {'title': '>= 2 working days', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At cycle 2 (28 days per cycle)', 'description': 'The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '85.9', 'groupId': 'OG000'}, {'value': '85.2', 'groupId': 'OG001'}]}]}, {'title': '4 working hours', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}, {'title': '1 working day', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}]}]}, {'title': '>= 2 working days', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At final examination (28 days)', 'description': 'The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.', 'unitOfMeasure': 'Dollars', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '5.46', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '30.00'}, {'value': '5.04', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '27.49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.', 'unitOfMeasure': 'Dollars', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '65.45'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '65.45'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.', 'unitOfMeasure': 'Dollars', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '60.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '295.98'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.', 'unitOfMeasure': 'Dollars', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '150.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '74.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.', 'unitOfMeasure': 'Dollars', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '271.68'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '98.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.', 'unitOfMeasure': 'Dollars', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '196.34'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '110.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.', 'unitOfMeasure': 'Dollars', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '30.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '10.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.', 'unitOfMeasure': 'Dollars', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '15.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '42.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. 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Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '68.2', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '67.2', 'spread': '16.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At final examination (28 days)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. 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Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '77.2', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '76.5', 'spread': '16.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At final examination (28 days)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '77.8', 'spread': '33.6', 'groupId': 'OG000'}, {'value': '79.4', 'spread': '32.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline cycle (28 days per cycle)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '89.6', 'spread': '23.0', 'groupId': 'OG000'}, {'value': '87.9', 'spread': '25.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At final examination (28 days)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '81.91', 'spread': '31.50', 'groupId': 'OG000'}, {'value': '79.18', 'spread': '34.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline cycle (28 days per cycle)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '88.64', 'spread': '26.36', 'groupId': 'OG000'}, {'value': '83.87', 'spread': '30.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At final examination (28 days)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'spread': '24.4', 'groupId': 'OG000'}, {'value': '51.8', 'spread': '23.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline cycle (28 days per cycle)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'OG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '77.0', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '74.0', 'spread': '22.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At final examination (28 days)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'FG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '253'}, {'groupId': 'FG001', 'numSubjects': '254'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '230'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '209'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not receive study medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}], 'recruitmentDetails': 'Participants aged 14 to 50 years with a need for oral contraception suffering from primary dysmenorrhea were recruited at specialized study sites.', 'preAssignmentDetails': 'Out of 771 participants screened, 264 failed screening, mostly due to not meeting in-/exclusion criteria (155), withdrawal of consent (49), loss to follow-up (36) or pregnancy (10). Thus, 507 participants were randomized (253 to Estradiol valerate/Dienogest and 254 to Ethinyl estradiol/Levonorgestrel).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '464', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'BG001', 'title': 'Ethinyl Estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '27.6', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '27.8', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'less than 18 years of age', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': '18 years of age or older', 'categories': [{'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '440', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '464', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 507}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-06', 'studyFirstSubmitDate': '2009-04-24', 'resultsFirstSubmitDate': '2011-11-15', 'studyFirstSubmitQcDate': '2009-05-28', 'lastUpdatePostDateStruct': {'date': '2015-08-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-21', 'studyFirstPostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).'}], 'secondaryOutcomes': [{'measure': 'Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst)'}, {'measure': 'Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).'}, {'measure': 'Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period).'}, {'measure': 'Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).'}, {'measure': 'Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).'}, {'measure': 'Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).'}, {'measure': 'Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)', 'timeFrame': 'baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)', 'description': 'Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).'}, {'measure': 'Percentage of Participants Satisfied With Study Treatment', 'timeFrame': 'From cycle 1 to cycle 3 (28 days per cycle)', 'description': 'Participants were asked to express the degree of their satisfaction with study treatment.'}, {'measure': 'Number of Days With Bleeding or Spotting', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting."}, {'measure': 'Number of Episodes With Bleeding or Spotting', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting."}, {'measure': 'Mean Length of Bleeding or Spotting Episodes', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting."}, {'measure': 'Maximum Length of Bleeding or Spotting Episodes', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting."}, {'measure': 'Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting."}, {'measure': 'Number of Days With Spotting-only', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting."}, {'measure': 'Number of Episodes With Spotting-only', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting."}, {'measure': 'Mean Length of Spotting Only Episodes', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting."}, {'measure': 'Maximum Length of Spotting Only Episodes', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting."}, {'measure': 'Difference in Duration Between Longest and Shortest Spotting Only Episode', 'timeFrame': 'From day 1 to day 90', 'description': "Bleeding/spotting episodes (day\\[s\\] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting."}, {'measure': 'Percentage of Participants With Withdrawal Bleeding at Cycle 1', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.'}, {'measure': 'Percentage of Participants With Withdrawal Bleeding at Cycle 3', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.'}, {'measure': 'Length of Withdrawal Bleeding Episodes at Cycle 1', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.'}, {'measure': 'Length of Withdrawal Bleeding Episodes at Cycle 3', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.'}, {'measure': 'Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.'}, {'measure': 'Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.'}, {'measure': 'Onset of Withdrawal Bleeding Episodes at Cycle 1', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.'}, {'measure': 'Onset of Withdrawal Bleeding Episodes at Cycle 3', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.'}, {'measure': 'Percentage of Participants With Intracyclic Bleeding at Cycle 1', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.'}, {'measure': 'Percentage of Participants With Intracyclic Bleeding at Cycle 3', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.'}, {'measure': 'Number of Intracyclic Bleeding Episodes at Cycle 1', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.'}, {'measure': 'Number of Intracyclic Bleeding Episodes at Cycle 3', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.'}, {'measure': 'Maximum Length of Intracyclic Bleeding Episodes at Cycle 1', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.'}, {'measure': 'Maximum Length of Intracyclic Bleeding Episodes at Cycle 3', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.'}, {'measure': 'Number of Intracyclic Bleeding Days at Cycle 1', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.'}, {'measure': 'Number of Intracyclic Bleeding Days at Cycle 3', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.'}, {'measure': 'Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1', 'timeFrame': 'At cycle 1 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.'}, {'measure': 'Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3', 'timeFrame': 'At cycle 3 (28 days per cycle)', 'description': 'Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.'}, {'measure': 'Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening', 'timeFrame': 'At screening (28 days)', 'description': 'The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.'}, {'measure': 'Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle', 'timeFrame': 'At Baseline (28 days per cycle)', 'description': 'The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.'}, {'measure': 'Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2', 'timeFrame': 'At cycle 2 (28 days per cycle)', 'description': 'The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.'}, {'measure': 'Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination', 'timeFrame': 'At final examination (28 days)', 'description': 'The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.'}, {'measure': 'Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.'}, {'measure': 'Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.'}, {'measure': 'Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.'}, {'measure': 'Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.'}, {'measure': 'Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.'}, {'measure': 'Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.'}, {'measure': 'Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.'}, {'measure': 'Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.'}, {'measure': 'Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire', 'timeFrame': 'At screening (average over 3 months before screening)', 'description': 'The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.'}, {'measure': "Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression", 'timeFrame': 'At cycle 2 (28 days per cycle)', 'description': "The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Investigators were asked to rate the participants' improvement during the course of the study."}, {'measure': "Participants With Improvement in Participants' Assessment in the Clinical Global Impression", 'timeFrame': 'At cycle 2 (28 days per cycle)', 'description': "The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Participants were asked to rate their improvement during the course of the study."}, {'measure': 'Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle', 'timeFrame': 'At baseline cycle (28 days per cycle)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination', 'timeFrame': 'at final examination (28 days)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle', 'timeFrame': 'At baseline cycle (28 days per cycle)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination', 'timeFrame': 'At final examination (28 days)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle', 'timeFrame': 'At baseline cycle (28 days per cycle)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination', 'timeFrame': 'At final examination (28 days)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle', 'timeFrame': 'At baseline cycle (28 days per cycle)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination', 'timeFrame': 'At final examination (28 days)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle', 'timeFrame': 'At baseline cycle (28 days per cycle)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination', 'timeFrame': 'At final examination (28 days)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle', 'timeFrame': 'At baseline cycle (28 days per cycle)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination', 'timeFrame': 'At final examination (28 days)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle', 'timeFrame': 'At baseline cycle (28 days per cycle)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination', 'timeFrame': 'At final examination (28 days)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle', 'timeFrame': 'At baseline cycle (28 days per cycle)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}, {'measure': 'Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination', 'timeFrame': 'At final examination (28 days)', 'description': 'The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary Dysmenorrhea', 'Oral Contraception'], 'conditions': ['Primary Dysmenorrhea']}, 'referencesModule': {'references': [{'pmid': '37523477', 'type': 'DERIVED', 'citation': 'Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.'}, {'pmid': '24713413', 'type': 'DERIVED', 'citation': 'Petraglia F, Parke S, Serrani M, Mellinger U, Romer T. Estradiol valerate plus dienogest versus ethinylestradiol plus levonorgestrel for the treatment of primary dysmenorrhea. Int J Gynaecol Obstet. 2014 Jun;125(3):270-4. doi: 10.1016/j.ijgo.2013.11.017. Epub 2014 Mar 11.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}]}, 'descriptionModule': {'briefSummary': 'To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of \\>/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score\n* Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent\n* Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)\n* Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1.\n* Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.\n\nExclusion Criteria:\n\n* Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)\n* Obesity: body mass index (BMI) \\> 32 kg/m2\n* Hypersensitivity to any of the study drug ingredients\n* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results\n* Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding\n* Abuse of alcohol, drugs, or medicines (e.g. laxatives)\n* Other contraceptive methods:\n\n * Sterilization\n * Oral, vaginal or transdermal hormonal contraception during treatment\n * Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1\n* Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator\n* Major surgery scheduled for the study period'}, 'identificationModule': {'nctId': 'NCT00909857', 'briefTitle': 'Effect on Primary Dysmenorrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea', 'orgStudyIdInfo': {'id': '91781'}, 'secondaryIdInfos': [{'id': '2008-005625-11', 'type': 'EUDRACT_NUMBER'}, {'id': '312042', 'type': 'OTHER', 'domain': 'Bayer'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles', 'interventionNames': ['Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'Drug: Placebo Match to SH T00658ID']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ethinyl estradiol, Levonorgestrel (Miranova)', 'description': 'Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles', 'interventionNames': ['Drug: Ethinyl estradiol, Levonorgestrel (Miranova)', 'Drug: Placebo Match to SH D593B']}], 'interventions': [{'name': 'Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)', 'type': 'DRUG', 'description': 'Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval', 'armGroupLabels': ['Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)']}, {'name': 'Ethinyl estradiol, Levonorgestrel (Miranova)', 'type': 'DRUG', 'description': 'Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval', 'armGroupLabels': ['Ethinyl estradiol, Levonorgestrel (Miranova)']}, {'name': 'Placebo Match to SH T00658ID', 'type': 'DRUG', 'description': 'Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment 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