Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT00461305
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2007-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004412', 'term': 'Dysmenorrhea'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C035144', 'term': 'drospirenone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'otherDetails': 'Sponsor will confirm the contents before disclosure.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)', 'otherNumAtRisk': 355, 'otherNumAffected': 335, 'seriousNumAtRisk': 355, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)', 'otherNumAtRisk': 65, 'otherNumAffected': 63, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 68, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 34, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 33, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 35, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 268, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 42, 'numAffected': 20}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 679, 'numAffected': 215}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 81, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 235, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 23, 'numAffected': 9}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 339, 'numAffected': 182}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 44, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 217, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 37, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Plasminogen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 38, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Breast discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 82, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Protein S decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Thrombin-antithrombin III complex increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 39, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood alkaline phosphatase decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Genital haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 194, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 26, 'numAffected': 14}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Coagulation test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 71, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Facial palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Intracyclic Bleeding at Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'OG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Incidence on one treatment arm', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.4', 'ciLowerLimit': '9.73', 'ciUpperLimit': '17.77', 'estimateComment': 'No group comparison were planned. Binomial parameter on each treatment arm was estimated by exact method.', 'groupDescription': 'Exact 95% confident intervals were calculated using F-distribution by treatment group. If the upper confidence limit is lower than 27.56% (threshold incidence), the treatment arm will be concluded to be acceptable. No group comparison was planned.', 'statisticalMethod': 'Binominal parameter by exact method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Incidence on one treatment arm', 'ciPctValue': '95', 'paramValue': '7.1', 'ciLowerLimit': '1.98', 'ciUpperLimit': '17.29', 'groupDescription': 'Exact 95% confident intervals were calculated using F-distribution by treatment group.', 'statisticalMethod': 'Binominal parameter by exact method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Intracyclic bleedings were defined as bleedings while a participant takes active tablets.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 6)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'OG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'classes': [{'title': '-6 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '-5 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '-4 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '-3 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '-2 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '-1 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '0 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '1 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '2 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '3 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '5 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '6 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 6)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}], 'classes': [{'title': '-6 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '-5 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': '-4 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': '-3 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': '-2 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': '-1 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': '0 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': '1 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '2 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '3 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '4 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '5 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6 (change in total dysmenorrhea scores)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)'}, {'type': 'SECONDARY', 'title': 'Distribution of Total Dysmenorrhea Score at Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'OG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 6)'}, {'type': 'SECONDARY', 'title': 'Distribution of Total Dysmenorrhea Score at Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. 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treatment duration 52 weeks (13 cycles)'}], 'classes': [{'title': 'none', 'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}]}]}, {'title': 'mild', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; 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treatment duration 52 weeks (13 cycles)'}], 'classes': [{'categories': [{'measurements': [{'value': '-41.6', 'groupId': 'OG000', 'lowerLimit': '-91', 'upperLimit': '36'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)'}, {'type': 'SECONDARY', 'title': 'Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'OG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '80'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '83'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 6)'}, {'type': 'SECONDARY', 'title': 'Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)'}, {'type': 'SECONDARY', 'title': 'Number of Any Bleeding Episodes From Cycle 1 to Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'OG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'classes': [{'title': 'Reference period 1', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '7'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '7'}]}]}, {'title': 'Reference period 2', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': "Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).", 'unitOfMeasure': 'number of episodes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)'}, {'type': 'SECONDARY', 'title': 'Number of Any Bleeding Episodes From Cycle 1 to Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}], 'classes': [{'title': 'Reference period 1', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '7'}]}]}, {'title': 'Reference period 2', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'Reference period 3', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Reference period 4', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': "Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).", 'unitOfMeasure': 'number of episodes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)'}, {'type': 'SECONDARY', 'title': 'Number of Any Bleeding Days From Cycle 1 to Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'OG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'classes': [{'title': 'Reference period 1', 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '65'}, {'value': '28.9', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '65'}]}]}, {'title': 'Reference period 2', 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '78'}, {'value': '19.9', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '42'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': "Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).", 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)'}, {'type': 'SECONDARY', 'title': 'Number of Any Bleeding Days From Cycle 1 to Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}], 'classes': [{'title': 'Reference period 1', 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '65'}]}]}, {'title': 'Reference period 2', 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '79'}]}]}, {'title': 'Reference period 3', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '88'}]}]}, {'title': 'Reference period 4', 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '69'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': "Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).", 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'OG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Intracyclic bleedings were defined as bleedings while a participant takes active tablets.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 9', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 10', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 11', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 12', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 13', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Intracyclic bleedings were defined as bleedings while a participant takes active tablets.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'OG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '276', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '310', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '302', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '279', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '274', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '314', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '307', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '289', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '285', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 9', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 10', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 11', 'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 12', 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 13', 'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'OG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000'}, {'value': '89.5', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 9', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 10', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 11', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 12', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 13', 'categories': [{'measurements': [{'value': '90.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'OG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000'}, {'value': '87.0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '90.8', 'groupId': 'OG000'}, {'value': '94.7', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '91.2', 'groupId': 'OG000'}, {'value': '87.9', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000'}, {'value': '92.6', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000'}, {'value': '88.9', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}, {'value': '88.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '90.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '91.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 9', 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 10', 'categories': [{'measurements': [{'value': '90.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 11', 'categories': [{'measurements': [{'value': '91.9', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 12', 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 13', 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)'}, {'type': 'SECONDARY', 'title': 'Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'OG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.33', 'groupId': 'OG000', 'lowerLimit': '-134.8', 'upperLimit': '46.1'}, {'value': '-5.50', 'groupId': 'OG001', 'lowerLimit': '-102.6', 'upperLimit': '3.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.', 'unitOfMeasure': 'Units/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS(Participants with data at Cycle 6)'}, {'type': 'SECONDARY', 'title': 'Change in Serum CA-125 From Baseline to Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.66', 'groupId': 'OG000', 'lowerLimit': '-135.5', 'upperLimit': '90.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.', 'unitOfMeasure': 'Units/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)'}, {'type': 'SECONDARY', 'title': 'Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'OG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.159', 'groupId': 'OG000', 'lowerLimit': '-0.83', 'upperLimit': '7.98'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '-1.62', 'upperLimit': '1.37'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS(Participants with data at Cycle 6)'}, {'type': 'SECONDARY', 'title': 'Change in Serum CRP From Baseline to Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.014', 'groupId': 'OG000', 'lowerLimit': '-0.90', 'upperLimit': '1.99'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)'}, {'type': 'POST_HOC', 'title': 'Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'OG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'classes': [{'title': 'age: < 30 years', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'age: >= 30 years', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'weight: < 50 kg', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '1.76', 'groupId': 'OG001'}]}]}, {'title': 'weight: >= 50kg', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'functional dysmenorrhea', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'organic dysmenorrhea', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'with medical surgical history', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'without medical surgical history', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '1.60', 'groupId': 'OG001'}]}]}, {'title': 'with previous medication', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.66', 'groupId': 'OG001'}]}]}, {'title': 'with pregnancy history', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.68', 'groupId': 'OG001'}]}]}, {'title': 'with birth history', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '1.83', 'groupId': 'OG001'}]}]}, {'title': 'total dysmenorrhea score at baseline 3/4', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'total dysmenorrhea score at baseline 5/6', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'POST_HOC', 'title': 'Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}], 'classes': [{'title': 'age: < 30 years', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.67', 'groupId': 'OG000'}]}]}, {'title': 'age: >= 30 years', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.70', 'groupId': 'OG000'}]}]}, {'title': 'weight: < 50 kg', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.68', 'groupId': 'OG000'}]}]}, {'title': 'weight: >= 50kg', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.65', 'groupId': 'OG000'}]}]}, {'title': 'functional dysmenorrhea', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.70', 'groupId': 'OG000'}]}]}, {'title': 'organic dysmenorrhea', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.59', 'groupId': 'OG000'}]}]}, {'title': 'with medical surgical history', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.72', 'groupId': 'OG000'}]}]}, {'title': 'without medical surgical history', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.64', 'groupId': 'OG000'}]}]}, {'title': 'with previous medication', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.69', 'groupId': 'OG000'}]}]}, {'title': 'with pregnancy history', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.75', 'groupId': 'OG000'}]}]}, {'title': 'with birth history', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.76', 'groupId': 'OG000'}]}]}, {'title': 'total dysmenorrhea score at baseline 3/4', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.48', 'groupId': 'OG000'}]}]}, {'title': 'total dysmenorrhea score at baseline 5/6', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}, {'id': 'FG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}], 'periods': [{'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Enrolled', 'groupId': 'FG000', 'numSubjects': '355'}, {'comment': 'Enrolled', 'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'Subjects Dispensed Drugs', 'achievements': [{'groupId': 'FG000', 'numSubjects': '350'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'Subjects Received Treatment', 'achievements': [{'comment': 'FAS, safety population', 'groupId': 'FG000', 'numSubjects': '349'}, {'comment': 'FAS, safety population', 'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '254'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Never dispensed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study drug not taken', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Partially missing diary', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other (missing drug etc)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Continued Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'FAS, participants from previous treatment who were available to continue treatment', 'groupId': 'FG000', 'numSubjects': '349'}, {'comment': 'no participants were treated with the DRSP 3 mg/EE 30 μg combination beyond 6 cycles', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '254'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Partially missing diary', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other (missing drug etc)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Full Analysis Set (FAS) consisted of all patients randomized who received at least one dose of study drug. Patients were analyzed as treated. FAS was the primary analysis set for the efficacy and safety. Per Protocol Set (PPS) was a subgroup of the FAS. The PPS consisted of patients in the FAS without major protocol deviations reported by Cycle 6.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '414', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DRSP 3 mg/EE 20 µg (13 Cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)'}, {'id': 'BG001', 'title': 'DRSP 3 mg/EE 30 µg (6 Cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '44'}, {'value': '30.9', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '43'}, {'value': '29.3', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '44'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '349', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '414', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis type', 'classes': [{'title': 'Functional dysmenorrhea', 'categories': [{'measurements': [{'value': '273', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}]}, {'title': 'Organic dysmenorrhea', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Details of organic dysmenorrhea', 'classes': [{'title': 'Endometriosis', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Uterine fibroids', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Uterine adenomyosis', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Endometrial polyp', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Bicornuate uterus', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Multiple endometrial polyp', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Uterine enlargement', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Not all participants had organic dysmenorrhea. Some of participants were diagnosed as having a multiple type of organic dysmenorrhea.', 'unitOfMeasure': 'participants'}, {'title': 'Average length of menstrual cycle', 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '38'}, {'value': '29.5', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '38'}, {'value': '29.5', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '38'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '20.73', 'groupId': 'BG000', 'lowerLimit': '16.2', 'upperLimit': '29.9'}, {'value': '20.56', 'groupId': 'BG001', 'lowerLimit': '15.3', 'upperLimit': '28.7'}, {'value': '20.70', 'groupId': 'BG002', 'lowerLimit': '15.3', 'upperLimit': '29.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-22', 'studyFirstSubmitDate': '2007-04-17', 'resultsFirstSubmitDate': '2010-09-10', 'studyFirstSubmitQcDate': '2007-04-17', 'lastUpdatePostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-09-10', 'studyFirstPostDateStruct': {'date': '2007-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Intracyclic Bleeding at Cycle 6', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Intracyclic bleedings were defined as bleedings while a participant takes active tablets.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6', 'timeFrame': 'From baseline up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.'}, {'measure': 'Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13', 'timeFrame': 'From baseline up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.'}, {'measure': 'Distribution of Total Dysmenorrhea Score at Cycle 6', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.'}, {'measure': 'Distribution of Total Dysmenorrhea Score at Cycle 13', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.'}, {'measure': 'Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).'}, {'measure': 'Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).'}, {'measure': 'Distribution of Severity of Lumbago During Menstruation at Cycle 6', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).'}, {'measure': 'Distribution of Severity of Lumbago During Menstruation at Cycle 13', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).'}, {'measure': 'Distribution of Severity of Headache During Menstruation at Cycle 6', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).'}, {'measure': 'Distribution of Severity of Headache During Menstruation at Cycle 13', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).'}, {'measure': 'Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).'}, {'measure': 'Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).'}, {'measure': 'Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.'}, {'measure': 'Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.'}, {'measure': 'Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6', 'timeFrame': 'From baseline up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).'}, {'measure': 'Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13', 'timeFrame': 'From baseline up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).'}, {'measure': 'Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6', 'timeFrame': 'From baseline up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).'}, {'measure': 'Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13', 'timeFrame': 'From baseline up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).'}, {'measure': 'Number of Any Bleeding Episodes From Cycle 1 to Cycle 6', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': "Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days)."}, {'measure': 'Number of Any Bleeding Episodes From Cycle 1 to Cycle 13', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': "Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days)."}, {'measure': 'Number of Any Bleeding Days From Cycle 1 to Cycle 6', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': "Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days)."}, {'measure': 'Number of Any Bleeding Days From Cycle 1 to Cycle 13', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': "Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days)."}, {'measure': 'Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Intracyclic bleedings were defined as bleedings while a participant takes active tablets.'}, {'measure': 'Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Intracyclic bleedings were defined as bleedings while a participant takes active tablets.'}, {'measure': 'Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.'}, {'measure': 'Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.'}, {'measure': 'Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).'}, {'measure': 'Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).'}, {'measure': 'Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6', 'timeFrame': 'Up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).'}, {'measure': 'Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13', 'timeFrame': 'Up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).'}, {'measure': 'Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6', 'timeFrame': 'From baseline up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.'}, {'measure': 'Change in Serum CA-125 From Baseline to Cycle 13', 'timeFrame': 'From baseline up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.'}, {'measure': 'Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6', 'timeFrame': 'From baseline up to Cycle 6 (168 days) with 28 days per cycle', 'description': 'CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.'}, {'measure': 'Change in Serum CRP From Baseline to Cycle 13', 'timeFrame': 'From baseline up to Cycle 13 (364 days) with 28 days per cycle', 'description': 'CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dysmenorrhea', 'Intracyclic bleeding', 'Drospirenone (DRSP)', 'Ethinylestradiol'], 'conditions': ['Dysmenorrhea']}, 'referencesModule': {'references': [{'pmid': '37523477', 'type': 'DERIVED', 'citation': 'Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety', 'detailedDescription': 'The "drospirenone 3 mg/ethinylestradiol 20 μg (13 cycles)" group is to be treated by oral administration for 52 weeks, 13 cycles. The "drospirenone 3 mg/ethinylestradiol 30 μg (6 cycles)" group is to be treated by oral administration for 24 weeks, 6 cycles.\n\nThe trial is sponsored by Bayer Yakuhin, Ltd.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 20 years or older at obtaining informed consent\n* Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment\n* Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment\n\nExclusion Criteria:\n\n* Patients with ovarian chocolate cysts\n* Patients with fibroid needed to be treated\n* Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer\n* Patients with undiagnosed abnormal vaginal bleeding\n* Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases\n* Patients aged 35 years or older who smoke at least 15 cigarettes per day\n* Patients with migraine accompanied by prodromata\n* Patients with pulmonary hypertension or valvular heart disease\n* Patients who are regularly taking nutritional products that contain St. John's Wort\n* Patients who underwent surgical treatment for endometriosis within 2 months prior to screening\n* Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)"}, 'identificationModule': {'nctId': 'NCT00461305', 'briefTitle': 'Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles)', 'orgStudyIdInfo': {'id': '91616'}, 'secondaryIdInfos': [{'id': '310284', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DRSP 3 mg/EE 20 µg (13 cycles)', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)', 'interventionNames': ['Drug: DRSP 3 mg/EE 20 µg (13 cycles)']}, {'type': 'EXPERIMENTAL', 'label': 'DRSP 3 mg/EE 30 µg (6 cycles)', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)', 'interventionNames': ['Drug: DRSP 3 mg/EE 30 µg (6 cycles)']}], 'interventions': [{'name': 'DRSP 3 mg/EE 20 µg (13 cycles)', 'type': 'DRUG', 'description': '1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)', 'armGroupLabels': ['DRSP 3 mg/EE 20 µg (13 cycles)']}, {'name': 'DRSP 3 mg/EE 30 µg (6 cycles)', 'type': 'DRUG', 'description': '1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)', 'armGroupLabels': ['DRSP 3 mg/EE 30 µg (6 cycles)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '460-0007', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '460-0011', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '464-0066', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '371-0024', 'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'zip': '370-0883', 'city': 'Takasaki', 'state': 'Gunma', 'country': 'Japan', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'zip': '650-0021', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '663-8204', 'city': 'Nishinomiya', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}, {'zip': '242-0007', 'city': 'Yamato', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.47276, 'lon': 139.45101}}, {'zip': '231-0861', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '980-0021', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '981-0933', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '984-0042', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '530-0013', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '534-0014', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '560-0022', 'city': 'Toyonaka', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.78244, 'lon': 135.46932}}, {'zip': '104-0061', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '192-0046', 'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'zip': '194-0022', 'city': 'Machida', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.54028, 'lon': 139.45083}}, {'zip': '180-0003', 'city': 'Musashino', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.70611, 'lon': 139.55944}}, {'zip': '144-0052', 'city': 'Ōta-ku', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.56126, 'lon': 139.71605}}, {'zip': '156-0042', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '157-0066', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '150-0013', 'city': 'Shibuya-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '140-0013', 'city': 'Shinagawa-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '167-0051', 'city': 'Suginami-ku', 'state': 'Tokyo', 'country': 'Japan'}, {'zip': '171-0021', 'city': 'Toshima-ku', 'state': 'Tokyo', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Therapeutic Area Head', 'oldOrganization': 'Bayer Yakuhin, Ltd.'}}}}