Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT00293059
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2006-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008796', 'term': 'Metrorrhagia'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'C023635', 'term': 'dienogest'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo', 'otherNumAtRisk': 119, 'otherNumAffected': 46, 'seriousNumAtRisk': 119, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily', 'otherNumAtRisk': 66, 'otherNumAffected': 21, 'seriousNumAtRisk': 66, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vaginitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 28, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.292', 'groupId': 'OG000'}, {'value': '0.029', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'inverting 2 one-sided tests', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'during a time period of 90 days under treatment', 'description': "Up to 8 criteria had to be met for complete response during 90-day period. No bleeding episodes (BE) \\>7 days, no \\>4 BE, no BE with MBL \\>=80 mL, no \\>1 BE increase from baseline, no increase from baseline in an individual participant's total number of bleeding days and total number of bleeding days not \\>24 days. Additionally, for participants included with prolonged bleeding: decrease between maximum duration during run-in and efficacy \\>=2 days excessive bleeding: MBL associated with each episode decreased by \\>=50% from average of qualifying episodes during run-in.", 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) group consisted of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Cured From Prolonged Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.154', 'groupId': 'OG000'}, {'value': '0.083', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during a time period of 90 days under treatment', 'description': 'Prolonged bleeding was defined as 2 or more bleeding episodes, each lasting 8 or more days in a 90-day period. Participants were considered cured if they had no bleeding episodes lasting more than 7 days and the decrease between the maximum duration during the run-in phase and the maximum duration during the efficacy phase was at least 2 days.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants who enrolled with prolonged bleeding.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Cured From Frequent Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.250', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during a time period of 90 days under treatment', 'description': 'Frequent bleeding was defined as greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall in a 90-day period. Participants were considered cured if they had no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and there was no increase in the total number of bleeding days in the efficacy phase as compared to the run-in phase.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants who enrolled with frequent bleeding.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Cured From Excessive Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.385', 'groupId': 'OG000'}, {'value': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during a time period of 90 days under treatment', 'description': 'Excessive bleeding was defined as 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day period. Participants were considered cured if (1) the blood loss volume associated with each episode was less than 80 mL and (2) the blood loss volume associated with each bleeding episode represented a decrease of at least 50% from the average of the qualifying bleeding episodes, where the qualifying bleeding episodes were those with a blood loss volume ≥ 80 mL (per episode) that occurred during the run-in phase.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants who enrolled with excessive bleeding.'}, {'type': 'SECONDARY', 'title': "Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84", 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.880', 'groupId': 'OG000'}, {'value': '0.509', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from baseline up to treatment day 84', 'description': "The investigators assessed the participants' change in DUB symptoms at day 84 (visit 7) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.", 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': "Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196", 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.807', 'groupId': 'OG000'}, {'value': '0.419', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from baseline up to treatment day 196', 'description': "The investigators assessed the participants' change in DUB symptoms at day 196 (visit 11) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less.", 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': "Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 84", 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.835', 'groupId': 'OG000'}, {'value': '0.426', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from baseline up to treatment day 84', 'description': 'Participants assessed their overall improvement at day 84 (visit 7) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': "Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 196", 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.812', 'groupId': 'OG000'}, {'value': '0.383', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from baseline up to treatment day 196', 'description': 'Participants assessed their overall improvement at day 196 (visit 11) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-353.1', 'spread': '309.4', 'groupId': 'OG000'}, {'value': '-130.4', 'spread': '338.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and reference period of 90 days under treatment', 'description': 'Menstrual blood loss was determined using the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. A negative value indicates a reduction in blood loss after treatment.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Menstrual Blood Loss Volume for All Participants at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '136.5', 'spread': '141.3', 'groupId': 'OG000'}, {'value': '146.9', 'spread': '133.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for one cycle', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Menstrual Blood Loss Volume for All Participants at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '91.5', 'groupId': 'OG000'}, {'value': '139.6', 'spread': '92.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for 3 cycles', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Menstrual Blood Loss Volume for All Participants at Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'spread': '54.2', 'groupId': 'OG000'}, {'value': '113.3', 'spread': '76.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Menstrual blood loss volume was determined using the alkaline hematin methods after participants were on treatment for 7 cycles', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-411.9', 'spread': '308.5', 'groupId': 'OG000'}, {'value': '-152.3', 'spread': '343.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and reference period of 90 days under treatment', 'description': 'The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, participants with excessive bleeding at baseline'}, {'type': 'SECONDARY', 'title': 'Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '206.1', 'spread': '179.8', 'groupId': 'OG000'}, {'value': '194.7', 'spread': '132.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for one cycle.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, participants with excessive bleeding at baseline'}, {'type': 'SECONDARY', 'title': 'Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '67.1', 'spread': '96.2', 'groupId': 'OG000'}, {'value': '147.4', 'spread': '93.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 3 cycles.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, participants with excessive bleeding at baseline'}, {'type': 'SECONDARY', 'title': 'Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'spread': '58.5', 'groupId': 'OG000'}, {'value': '116.9', 'spread': '77.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 7 cycles.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, participants with excessive bleeding at baseline'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.2', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and reference period of 90 days under treatment', 'description': 'The number of bleeding days was determine for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline.', 'unitOfMeasure': 'bleeding days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and reference period of 90 days under treatment', 'description': 'A bleeding episode was one that lasted for at least 2 days, and where the bleeding days were separated by no more than 1 bleeding-free day. An episode stopped with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. A negative values indicates a reduction from baseline in the number of episodes while under treatment.', 'unitOfMeasure': 'bleeding episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.6', 'spread': '40.9', 'groupId': 'OG000'}, {'value': '-21.2', 'spread': '43.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and reference period of 90 days under treatment', 'description': 'The number of total sanitary protection items used during the 90-day run-in phase before treatment (baseline) and the number of total sanitary protection items used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to the number used before treatment.', 'unitOfMeasure': 'Sanitary protection products', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '10.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and treatment day 84', 'description': 'The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '10.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and treatment day 196', 'description': 'The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and treatment day 84', 'description': "The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '9.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and treatment day 196', 'description': "The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0035', 'spread': '0.2145', 'groupId': 'OG000'}, {'value': '-0.0024', 'spread': '0.1507', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and treatment day 84', 'description': 'The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 84 is presented.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0052', 'spread': '0.1504', 'groupId': 'OG000'}, {'value': '0.0154', 'spread': '0.1611', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and treatment day 196', 'description': 'The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 196 is presented.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.07', 'spread': '11.74', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '10.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and treatment day 84', 'description': 'The visual analogue scale (ie, "thermometer") had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked \'your own health state today\' to the appropriate point on the thermometer scale. The change from baseline at day 84 is presented.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '12.86', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '12.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and treatment day 196', 'description': 'The visual analogue scale (ie, "thermometer") had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked \'your own health state today\' to the appropriate point on the thermometer scale. The change from baseline at day 196 is presented.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.221', 'groupId': 'OG000'}, {'value': '0.106', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked if there was any change in her employment status in the last 12 weeks. The proportion of participants with a change is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked how many days and hours they missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.', 'unitOfMeasure': 'day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.38', 'spread': '2.175', 'groupId': 'OG000'}, {'value': '3.07', 'spread': '2.088', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked to rate on a scale of 0 to 10, how much their DUB affected productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.81', 'spread': '2.551', 'groupId': 'OG000'}, {'value': '3.91', 'spread': '2.466', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do their regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing daily activities.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.012', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.012', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.012', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who received such services is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.323', 'groupId': 'OG000'}, {'value': '0.407', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked to specify if they had out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.047', 'groupId': 'OG000'}, {'value': '0.062', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.129', 'groupId': 'OG000'}, {'value': '0.213', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked if there was any change in employment status in the last 12 weeks. The proportion of participants with a change is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked how many days and hours were missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.40', 'spread': '2.293', 'groupId': 'OG000'}, {'value': '4.03', 'spread': '3.123', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked to rate on a scale of 0 to 10, how much DUB affected their productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.48', 'spread': '2.291', 'groupId': 'OG000'}, {'value': '4.10', 'spread': '2.903', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing her daily activities.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.012', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.024', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.024', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.012', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who had received such services is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.241', 'groupId': 'OG000'}, {'value': '0.314', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked to specify out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication, co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.047', 'groupId': 'OG000'}, {'value': '0.043', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.30', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '3.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and treatment day 196', 'description': 'Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196.', 'unitOfMeasure': 'Percentage of blood volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Ferritin Concentration at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '35.6', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '12.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and treatment day 84', 'description': 'Serum ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 84.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Ferritin Concentration at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '37.8', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '11.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and treatment day 196', 'description': 'Serum ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 196.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin Concentration at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and treatment day 84', 'description': 'Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin Concentration at Treatment Day 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.57', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and treatment day 196', 'description': 'Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, excluding participants with missing data'}, {'type': 'POST_HOC', 'title': 'Proportion of Participants With Successful Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'title': 'End of study MBL <=80 mL', 'categories': [{'measurements': [{'value': '0.568', 'groupId': 'OG000'}, {'value': '0.183', 'groupId': 'OG001'}]}]}, {'title': 'Decrease MBL >=50% of baseline MBL', 'categories': [{'measurements': [{'value': '0.568', 'groupId': 'OG000'}, {'value': '0.217', 'groupId': 'OG001'}]}]}, {'title': 'Successful treatment', 'categories': [{'measurements': [{'value': '0.511', 'groupId': 'OG000'}, {'value': '0.133', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during a time period of 28 days under treatment', 'description': 'End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with heavy menstrual bleeding were included in the analysis.'}, {'type': 'POST_HOC', 'title': 'Change in Absolute Value From Baseline MBL to end-of Study MBL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-114.60', 'spread': '138.712', 'groupId': 'OG000'}, {'value': '-49.944', 'spread': '117.038', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during a time period of 28 days under treatment', 'description': 'The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied).', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with heavy menstrual bleeding were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'Subjects Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'Cycle 1/Treatment Day 28', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'Cycle 3/Treatment Day 84', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'Cycle 7/Treatment Day 196', 'achievements': [{'comment': 'Includes participants that prematurely discontinued and may not be counted in earlier visits.', 'groupId': 'FG000', 'numSubjects': '113'}, {'comment': 'Includes participants that prematurely discontinued and may not be counted in earlier visits.', 'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Participant moved out of state', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant stopped study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Noncompliant - sanitary pads collection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'The date of first participant, first visit was 14 Dec 2005. The date of last participant, last visit was 21 May 2008.', 'preAssignmentDetails': 'A total of 1077 participants were screened for inclusion into the study; 887 participants failed screening. The remaining 190 participants were randomized; 120 participants were randomized to the estradiol valerate/dienogest group and 70 participants to the placebo group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching placebo to be taken orally daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '37.0', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '36.9', 'spread': '7.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '25.8', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '26.1', 'spread': '3.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'excessive bleeding', 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': '2 or more bleeding episodes in the 90-day run-in phase, each with blood loss ≥80 mL', 'unitOfMeasure': 'participants'}, {'title': 'prolonged bleeding', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': '2 or more bleeding episodes in the 90-day run-in phase, each lasting 8 or more days', 'unitOfMeasure': 'participants'}, {'title': 'frequent bleeding', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': '\\> 5 bleeding episodes in the 90-day run-in phase, with a minimum of 20 bleeding days overall', 'unitOfMeasure': 'participants'}, {'title': 'prolonged and frequent bleeding', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'prolonged and excessive bleeding', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'frequent and excessive bleeding', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'prolonged, frequent and excessive bleeding', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2006-02-15', 'resultsFirstSubmitDate': '2011-02-23', 'studyFirstSubmitQcDate': '2006-02-16', 'lastUpdatePostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-04', 'studyFirstPostDateStruct': {'date': '2006-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms', 'timeFrame': 'during a time period of 90 days under treatment', 'description': "Up to 8 criteria had to be met for complete response during 90-day period. No bleeding episodes (BE) \\>7 days, no \\>4 BE, no BE with MBL \\>=80 mL, no \\>1 BE increase from baseline, no increase from baseline in an individual participant's total number of bleeding days and total number of bleeding days not \\>24 days. Additionally, for participants included with prolonged bleeding: decrease between maximum duration during run-in and efficacy \\>=2 days excessive bleeding: MBL associated with each episode decreased by \\>=50% from average of qualifying episodes during run-in."}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Cured From Prolonged Bleeding', 'timeFrame': 'during a time period of 90 days under treatment', 'description': 'Prolonged bleeding was defined as 2 or more bleeding episodes, each lasting 8 or more days in a 90-day period. Participants were considered cured if they had no bleeding episodes lasting more than 7 days and the decrease between the maximum duration during the run-in phase and the maximum duration during the efficacy phase was at least 2 days.'}, {'measure': 'Proportion of Participants Cured From Frequent Bleeding', 'timeFrame': 'during a time period of 90 days under treatment', 'description': 'Frequent bleeding was defined as greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall in a 90-day period. Participants were considered cured if they had no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and there was no increase in the total number of bleeding days in the efficacy phase as compared to the run-in phase.'}, {'measure': 'Proportion of Participants Cured From Excessive Bleeding', 'timeFrame': 'during a time period of 90 days under treatment', 'description': 'Excessive bleeding was defined as 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day period. Participants were considered cured if (1) the blood loss volume associated with each episode was less than 80 mL and (2) the blood loss volume associated with each bleeding episode represented a decrease of at least 50% from the average of the qualifying bleeding episodes, where the qualifying bleeding episodes were those with a blood loss volume ≥ 80 mL (per episode) that occurred during the run-in phase.'}, {'measure': "Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 84", 'timeFrame': 'from baseline up to treatment day 84', 'description': "The investigators assessed the participants' change in DUB symptoms at day 84 (visit 7) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less."}, {'measure': "Proportion of Participants With Improvement in the Investigator's Global Assessment Scale at Treatment Day 196", 'timeFrame': 'from baseline up to treatment day 196', 'description': "The investigators assessed the participants' change in DUB symptoms at day 196 (visit 11) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less."}, {'measure': "Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 84", 'timeFrame': 'from baseline up to treatment day 84', 'description': 'Participants assessed their overall improvement at day 84 (visit 7) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.'}, {'measure': "Proportion of Participants With Improvement in the Participant's Overall Assessment Scale at Treatment Day 196", 'timeFrame': 'from baseline up to treatment day 196', 'description': 'Participants assessed their overall improvement at day 196 (visit 11) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less.'}, {'measure': 'Change From Baseline in Blood Loss Volume for All Participants to the Reference Period of 90 Days Under Treatment', 'timeFrame': 'Baseline and reference period of 90 days under treatment', 'description': 'Menstrual blood loss was determined using the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. A negative value indicates a reduction in blood loss after treatment.'}, {'measure': 'Menstrual Blood Loss Volume for All Participants at Cycle 1', 'timeFrame': '28 days', 'description': 'Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for one cycle'}, {'measure': 'Menstrual Blood Loss Volume for All Participants at Cycle 3', 'timeFrame': '28 days', 'description': 'Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for 3 cycles'}, {'measure': 'Menstrual Blood Loss Volume for All Participants at Cycle 7', 'timeFrame': '28 days', 'description': 'Menstrual blood loss volume was determined using the alkaline hematin methods after participants were on treatment for 7 cycles'}, {'measure': 'Change From Baseline in Blood Loss Volume for Participants With Excessive Bleeding to the Reference Period of 90 Days Under Treatment', 'timeFrame': 'baseline and reference period of 90 days under treatment', 'description': 'The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment.'}, {'measure': 'Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 1', 'timeFrame': '28 days', 'description': 'The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for one cycle.'}, {'measure': 'Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 3', 'timeFrame': '28 days', 'description': 'The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 3 cycles.'}, {'measure': 'Menstrual Blood Loss Volume for Participants With Excessive Bleeding at Cycle 7', 'timeFrame': '28 days', 'description': 'The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 7 cycles.'}, {'measure': 'Change From Baseline in Number of Bleeding Days to the Reference Period of 90 Days Under Treatment', 'timeFrame': 'baseline and reference period of 90 days under treatment', 'description': 'The number of bleeding days was determine for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline.'}, {'measure': 'Change From Baseline in Number of Bleeding Episodes to the Reference Period of 90 Days Under Treatment', 'timeFrame': 'baseline and reference period of 90 days under treatment', 'description': 'A bleeding episode was one that lasted for at least 2 days, and where the bleeding days were separated by no more than 1 bleeding-free day. An episode stopped with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. A negative values indicates a reduction from baseline in the number of episodes while under treatment.'}, {'measure': 'Change From Baseline in Number of Sanitary Protection Used at 90 Days of Treatment', 'timeFrame': 'baseline and reference period of 90 days under treatment', 'description': 'The number of total sanitary protection items used during the 90-day run-in phase before treatment (baseline) and the number of total sanitary protection items used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to the number used before treatment.'}, {'measure': 'Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 84', 'timeFrame': 'baseline and treatment day 84', 'description': 'The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.'}, {'measure': 'Change From Baseline in Psychological General Well-Being Index (PGWBI) Scores at Treatment Day 196', 'timeFrame': 'baseline and treatment day 196', 'description': 'The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively.'}, {'measure': 'Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 84', 'timeFrame': 'baseline and treatment day 84', 'description': "The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133."}, {'measure': 'Change From Baseline in McCoy Female Sexuality Questionnaire (MFSQ) Scores at Treatment Day 196', 'timeFrame': 'baseline and treatment day 196', 'description': "The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133."}, {'measure': 'Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 84', 'timeFrame': 'baseline and treatment day 84', 'description': 'The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 84 is presented.'}, {'measure': 'Change From Baseline in EuroQoL (Quality of Life) 5 Dimensional Health Questionnaire (EQ-5D) Scores at Treatment Day 196', 'timeFrame': 'baseline and treatment day 196', 'description': 'The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 196 is presented.'}, {'measure': 'Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 84', 'timeFrame': 'baseline and treatment day 84', 'description': 'The visual analogue scale (ie, "thermometer") had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked \'your own health state today\' to the appropriate point on the thermometer scale. The change from baseline at day 84 is presented.'}, {'measure': 'Change From Baseline in Visual Analogue Scale (VAS) of the EQ-5D Score at Treatment Day 196', 'timeFrame': 'baseline and treatment day 196', 'description': 'The visual analogue scale (ie, "thermometer") had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked \'your own health state today\' to the appropriate point on the thermometer scale. The change from baseline at day 196 is presented.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 84', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked if there was any change in her employment status in the last 12 weeks. The proportion of participants with a change is displayed.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 84', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked how many days and hours they missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 84', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked to rate on a scale of 0 to 10, how much their DUB affected productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 84', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do their regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing daily activities.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 84', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 84', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 84', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 84', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who received such services is displayed.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 84', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked to specify if they had out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 84', 'timeFrame': 'treatment day 84', 'description': 'Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Change in the Employment Status) at Treatment Day 196', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked if there was any change in employment status in the last 12 weeks. The proportion of participants with a change is displayed.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Days Missed From Work) at Treatment Day 196', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked how many days and hours were missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Productivity While Working) at Treatment Day 196', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked to rate on a scale of 0 to 10, how much DUB affected their productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Regular Daily Activities) at Treatment Day 196', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing her daily activities.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Outpatient Visit at Hospital) at Treatment Day 196', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Unscheduled Visit to Physician) at Treatment Day 196', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Additional Unscheduled Procedures) at Treatment Day 196', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Received Ambulatory Services) at Treatment Day 196', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who had received such services is displayed.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Out-of-pocket Expenses) at Treatment Day 196', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked to specify out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication, co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed.'}, {'measure': 'Resource Use Assessment by Use of a Self Administered Questionnaire (Any Medical Treatment) at Treatment Day 196', 'timeFrame': 'treatment day 196', 'description': 'Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed.'}, {'measure': 'Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 196', 'timeFrame': 'baseline and treatment day 196', 'description': 'Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196.'}, {'measure': 'Change From Baseline in Serum Ferritin Concentration at Treatment Day 84', 'timeFrame': 'baseline and treatment day 84', 'description': 'Serum ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 84.'}, {'measure': 'Change From Baseline in Serum Ferritin Concentration at Treatment Day 196', 'timeFrame': 'baseline and treatment day 196', 'description': 'Serum ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 196.'}, {'measure': 'Change From Baseline in Hemoglobin Concentration at Treatment Day 84', 'timeFrame': 'baseline and treatment day 84', 'description': 'Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84.'}, {'measure': 'Change From Baseline in Hemoglobin Concentration at Treatment Day 196', 'timeFrame': 'baseline and treatment day 196', 'description': 'Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dysfunctional Uterine Bleeding'], 'conditions': ['Metrorrhagia']}, 'referencesModule': {'references': [{'pmid': '22240178', 'type': 'RESULT', 'citation': 'Fraser IS, Jensen J, Schaefers M, Mellinger U, Parke S, Serrani M. Normalization of blood loss in women with heavy menstrual bleeding treated with an oral contraceptive containing estradiol valerate/dienogest. Contraception. 2012 Aug;86(2):96-101. doi: 10.1016/j.contraception.2011.11.011. Epub 2012 Jan 10.'}, {'pmid': '21422847', 'type': 'RESULT', 'citation': 'Jensen JT, Parke S, Mellinger U, Machlitt A, Fraser IS. Effective treatment of heavy menstrual bleeding with estradiol valerate and dienogest: a randomized controlled trial. Obstet Gynecol. 2011 Apr;117(4):777-787. doi: 10.1097/AOG.0b013e3182118ac3.'}, {'pmid': '21774563', 'type': 'RESULT', 'citation': 'Fraser IS, Parke S, Mellinger U, Machlitt A, Serrani M, Jensen J. Effective treatment of heavy and/or prolonged menstrual bleeding without organic cause: pooled analysis of two multinational, randomised, double-blind, placebo-controlled trials of oestradiol valerate and dienogest. Eur J Contracept Reprod Health Care. 2011 Aug;16(4):258-69. doi: 10.3109/13625187.2011.591456.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.', 'detailedDescription': 'This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18 years or older\n* With diagnosis of dysfunctional uterine bleeding without organic pathology\n* And with at least one of the following symptoms: prolonged, frequent, or excessive bleeding\n\nExclusion Criteria:\n\n* The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.\n* Women with history of endometrial ablation or dilatation or curettage within 2 months prior to study start will be excluded.'}, 'identificationModule': {'nctId': 'NCT00293059', 'briefTitle': 'Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo- Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol Valerate/Dienogest Tablets for the Treatment of Dysfunctional Uterine Bleeding.', 'orgStudyIdInfo': {'id': '91469'}, 'secondaryIdInfos': [{'id': '308960', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'description': 'A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo', 'interventionNames': ['Drug: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo to be taken orally daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)', 'type': 'DRUG', 'description': '2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placeboA blister card consists of 28 pills taken orally once a day for 28 days (one cycle)', 'armGroupLabels': ['Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo to be taken orally daily.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86403', 'city': 'Lake Havasu City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Women and Child, LPP', 'geoPoint': {'lat': 34.4839, 'lon': -114.32245}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Marin Endocrine Associates', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '90010', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Impact Clinical Trials - Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90272', 'city': 'Pacific Palisades', 'state': 'California', 'country': 'United States', 'facility': 'Blue Hill Medical Group', 'geoPoint': {'lat': 34.04806, 'lon': -118.52647}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Genesis Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Women's Health Care, Inc.", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'Clinical Trial Center of Colorado', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '80122', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Clinical Trial Center of Colorado', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida Medical Research', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33759', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': "Women's Medical Research Group, LLC", 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33916', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Physiology Associates, Inc.', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'New Age Medical Research Corp.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Insignia Care for Women, P.A.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Mount Vernon Clinical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30134', 'city': 'Douglasville', 'state': 'Georgia', 'country': 'United States', 'facility': "Atlanta West Women's Center", 'geoPoint': {'lat': 33.7515, 'lon': -84.74771}}, {'zip': '61820', 'city': 'Champaign', 'state': 'Illinois', 'country': 'United States', 'facility': "Women's Health Practice", 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Physicians Research Group', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Advanced Biomedical Research of America', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28562', 'city': 'New Bern', 'state': 'North Carolina', 'country': 'United States', 'facility': "Eastern Carolina Women's Center", 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hawthorne Medical Research, Inc.', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58501', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Womens Medical Center', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Reproductive Medical Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Rapid Medical Research Inc.', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Research of Philadelphia, LLC', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19464', 'city': 'Pottstown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Women's Health Care Group of PA", 'geoPoint': {'lat': 40.24537, 'lon': -75.64963}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'South Carolina Clinical Research Center', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '57201', 'city': 'Watertown', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Brown Clinic, P.L.L.P.', 'geoPoint': {'lat': 44.89941, 'lon': -97.11507}}, {'zip': '37043', 'city': 'Clarksville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'New South Medical', 'geoPoint': {'lat': 36.52977, 'lon': -87.35945}}, {'zip': '78414', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Research Associates', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Obstetrical & Gynecological Associates, PA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Across America', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'National Clinical Research, Inc.', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '99207', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': "North Spokane Women's Clinic", 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Dr. John Lenihan, MD', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': 'E2A 4X7', 'city': 'Bathurst', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Maritimes Research Center', 'geoPoint': {'lat': 47.61814, 'lon': -65.65112}}, {'zip': 'N2C 2N9', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Total Concept Health Care Inc.', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'M4S 1Y2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Prime Health Research', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 1P6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre d'étude clinique de Montréal Inc.", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2X 1N8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Les Gynecologues Associes', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1S 2L6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique Recherche en Sante des Femmes Inc.', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G9N 2H6', 'city': 'Shawinigan', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique de Gynecologie', 'geoPoint': {'lat': 46.56675, 'lon': -72.74913}}, {'zip': 'J1H 4J6', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Q & T Research, Inc.', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'G1V 4X7', 'city': 'Ste-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique Médicale des Campus'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}