Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-20 @ 6:52 PM
Study NCT ID:
NCT02691494
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2016-02-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D008595', 'term': 'Menorrhagia'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C539351', 'term': 'elagolix'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D000077563', 'term': 'Norethindrone Acetate'}, {'id': 'C418365', 'term': 'estradiol, norethindrone drug combination'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009640', 'term': 'Norethindrone'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 160.3 (51.75), 155.2 (65.19), and 158.7 (54.68) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively', 'description': 'Treatment-emergent adverse events are presented.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo for both elagolix BID and E2/NETA QD', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 34, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Elagolix', 'description': 'Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 58, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Elagolix + E2-NETA', 'description': 'Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD', 'otherNumAtRisk': 189, 'deathsNumAtRisk': 189, 'otherNumAffected': 80, 'seriousNumAtRisk': 189, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'LIBIDO DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'MOOD SWINGS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'DYSMENORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'NIGHT SWEATS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HOT FLUSH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 41, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 37, 'numAffected': 37}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HYPERTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'SMALL INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'CHOLELITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'OBESITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ABORTION COMPLETE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'DYSFUNCTIONAL UTERINE BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'DYSMENORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'MENORRHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'PELVIC PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Meeting the Criteria for Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for both elagolix BID and E2/NETA QD'}, {'id': 'OG001', 'title': 'Elagolix', 'description': 'Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}, {'id': 'OG002', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '76.9', 'groupId': 'OG001'}, {'value': '76.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.73', 'ciLowerLimit': '12.248', 'ciUpperLimit': '67.387', 'pValueComment': 'The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.31', 'ciLowerLimit': '13.042', 'ciUpperLimit': '61.431', 'pValueComment': 'The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Final Month (the last 28 days prior to and including the Reference Day), up to Month 6', 'description': 'Percentage of responders, defined as participants who met the following conditions:\n\n* Menstrual blood loss (MBL) volume \\< 80 mL during the Final Month (the last 28 days prior to and including the Reference Day, which is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date), and\n* ≥ 50% reduction in MBL volume from Baseline to the Final Month.\n\nParticipants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MBL Volume to the Final Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for both elagolix BID and E2/NETA QD'}, {'id': 'OG001', 'title': 'Elagolix', 'description': 'Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}, {'id': 'OG002', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'spread': '15.44', 'groupId': 'OG000'}, {'value': '-198.8', 'spread': '15.44', 'groupId': 'OG001'}, {'value': '-168.8', 'spread': '10.72', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-194.5', 'pValueComment': 'The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.70', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-164.6', 'pValueComment': 'The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.87', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Final Month (the last 28 days prior to and including the Reference Day), up to Month 6', 'description': 'Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.\n\nThe Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Suppression of Bleeding at the Final Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for both elagolix BID and E2/NETA QD'}, {'id': 'OG001', 'title': 'Elagolix', 'description': 'Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}, {'id': 'OG002', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '88.9', 'groupId': 'OG001'}, {'value': '61.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Between-Group Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '84.2', 'ciLowerLimit': '75.99', 'ciUpperLimit': '92.37', 'pValueComment': "The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \\< 5).", 'statisticalMethod': "chi-square or Fisher's exact test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Between-Group Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '56.3', 'ciLowerLimit': '47.77', 'ciUpperLimit': '64.91', 'pValueComment': "The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \\< 5).", 'statisticalMethod': "chi-square or Fisher's exact test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Final Month (the last 28 days prior to and including the Reference Day), up to Month 6', 'description': 'Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.\n\nThe Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants with an assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MBL Volume to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for both elagolix BID and E2/NETA QD'}, {'id': 'OG001', 'title': 'Elagolix', 'description': 'Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}, {'id': 'OG002', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}], 'classes': [{'categories': [{'measurements': [{'value': '28.5', 'spread': '16.68', 'groupId': 'OG000'}, {'value': '-223.7', 'spread': '17.98', 'groupId': 'OG001'}, {'value': '-198.1', 'spread': '11.89', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-252.3', 'pValueComment': 'The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '24.53', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-226.6', 'pValueComment': 'The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.50', 'statisticalMethod': 'mixed model repeated 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'Placebo for both elagolix BID and E2/NETA QD'}, {'id': 'OG001', 'title': 'Elagolix', 'description': 'Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}, {'id': 'OG002', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.2', 'spread': '11.57', 'groupId': 'OG000'}, {'value': '-211.1', 'spread': '11.96', 'groupId': 'OG001'}, {'value': '-200.3', 'spread': '8.17', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-196.9', 'pValueComment': 'The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.66', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean of Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-186.1', 'pValueComment': 'The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.18', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 0 (Baseline), Month 3', 'description': 'Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary 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Fisher's exact test if ≥ 20% of the cells have expected cell count \\< 5).", 'statisticalMethod': "chi-square or Fisher's exact test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0 (Baseline), Month 6', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants with baseline hemoglobin \\<= 10.5 g/dL and an assessment at Month 6.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MBL Volume to Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for both elagolix BID and E2/NETA QD'}, {'id': 'OG001', 'title': 'Elagolix', 'description': 'Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}, {'id': 'OG002', 'title': 'Elagolix + 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'TWO_SIDED', 'paramValue': '-125.0', 'pValueComment': 'The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.55', 'statisticalMethod': 'mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 0 (Baseline), Month 1', 'description': 'Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants with an assessment at given time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo for both elagolix BID and E2/NETA QD'}, {'id': 'FG001', 'title': 'Elagolix', 'description': 'Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}, {'id': 'FG002', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': 'randomized and treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '95'}, {'groupId': 'FG002', 'numSubjects': '189'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'completed treatment period', 'groupId': 'FG000', 'numSubjects': '72'}, {'comment': 'completed treatment period', 'groupId': 'FG001', 'numSubjects': '69'}, {'comment': 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'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Required Surgery/Invasive Intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Eligible participants were randomized in a 1:1:2 ratio to 1 of 3 treatment groups: placebo, elagolix 300 mg BID, or elagolix 300 mg twice daily (BID) plus estradiol/norethindrone acetate (E2/NETA) once daily (QD).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}, {'value': '378', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo for both elagolix BID and E2/NETA QD'}, {'id': 'BG001', 'title': 'Elagolix', 'description': 'Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}, {'id': 'BG002', 'title': 'Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '5.43', 'groupId': 'BG000'}, {'value': '42.2', 'spread': '5.41', 'groupId': 'BG001'}, {'value': '42.5', 'spread': '5.33', 'groupId': 'BG002'}, {'value': '42.4', 'spread': '5.36', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}, {'value': '378', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '319', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '253', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-06', 'size': 1740840, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-10T16:00', 'hasProtocol': True}, {'date': '2018-02-02', 'size': 1883182, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-10T16:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 378}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'dispFirstSubmitDate': '2019-02-05', 'completionDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-09', 'studyFirstSubmitDate': '2016-02-22', 'dispFirstSubmitQcDate': '2019-02-05', 'resultsFirstSubmitDate': '2020-06-12', 'studyFirstSubmitQcDate': '2016-02-22', 'dispFirstPostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-12', 'studyFirstPostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Meeting the Criteria for Responder', 'timeFrame': 'Final Month (the last 28 days prior to and including the Reference Day), up to Month 6', 'description': 'Percentage of responders, defined as participants who met the following conditions:\n\n* Menstrual blood loss (MBL) volume \\< 80 mL during the Final Month (the last 28 days prior to and including the Reference Day, which is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date), and\n* ≥ 50% reduction in MBL volume from Baseline to the Final Month.\n\nParticipants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in MBL Volume to the Final Month', 'timeFrame': 'Baseline and Final Month (the last 28 days prior to and including the Reference Day), up to Month 6', 'description': 'Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.\n\nThe Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.'}, {'measure': 'Percentage of Participants With Suppression of Bleeding at the Final Month', 'timeFrame': 'Final Month (the last 28 days prior to and including the Reference Day), up to Month 6', 'description': 'Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.\n\nThe Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.'}, {'measure': 'Change From Baseline in MBL Volume to Month 6', 'timeFrame': 'Month 0 (Baseline), Month 6', 'description': 'Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.'}, {'measure': 'Change From Baseline in MBL Volume to Month 3', 'timeFrame': 'Month 0 (Baseline), Month 3', 'description': 'Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.'}, {'measure': 'Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6', 'timeFrame': 'Month 0 (Baseline), Month 6'}, {'measure': 'Change From Baseline in MBL Volume to Month 1', 'timeFrame': 'Month 0 (Baseline), Month 1', 'description': 'Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elagolix', 'Elagolix Sodium', 'Heavy uterine bleeding', 'Heavy menstrual bleeding (HMB)', 'Leiomyomata', 'Menorrhagia', 'ABT-620', 'Elagolix + E2/NETA (Elagolix + Norethindrone acetate)'], 'conditions': ['Uterine Fibroids', 'Heavy Menstrual Bleeding']}, 'referencesModule': {'references': [{'pmid': '39381651', 'type': 'DERIVED', 'citation': 'Simon JA, Stewart EA, Jewell S, Li M, Snabes MC. Impact of demographic and clinical factors on elagolix plus add-back therapy effects on patient-reported nonbleeding symptoms in women with heavy menstrual bleeding and uterine fibroids: a post hoc analysis of data from two clinical trials. F S Rep. 2024 Jun 14;5(3):285-295. doi: 10.1016/j.xfre.2024.06.002. eCollection 2024 Sep.'}, {'pmid': '34878624', 'type': 'DERIVED', 'citation': 'Beck D, Winzenborg I, Liu M, Degner J, Mostafa NM, Noertersheuser P, Shebley M. Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids. Clin Pharmacokinet. 2022 Apr;61(4):577-587. doi: 10.1007/s40262-021-01096-w. Epub 2021 Dec 8.'}, {'pmid': '34582715', 'type': 'DERIVED', 'citation': 'Stewart EA, Archer DF, Owens CD, Barnhart KT, Bradley LD, Feinberg EC, Gillispie-Bell V, Imudia AN, Liu R, Kim JH, Al-Hendy A. Reduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine Fibroids. J Womens Health (Larchmt). 2022 May;31(5):698-705. doi: 10.1089/jwh.2021.0152. Epub 2021 Sep 28.'}, {'pmid': '34553161', 'type': 'DERIVED', 'citation': 'Muneyyirci-Delale O, Archer DF, Owens CD, Barnhart KT, Bradley LD, Feinberg E, Gillispie V, Hurtado S, Kim JH, Wang A, Wang H, Stewart EA. Efficacy and safety of elagolix with add-back therapy in women with uterine fibroids and coexisting adenomyosis. F S Rep. 2021 May 26;2(3):338-346. doi: 10.1016/j.xfre.2021.05.004. eCollection 2021 Sep.'}, {'pmid': '33650259', 'type': 'DERIVED', 'citation': 'Beck D, Winzenborg I, Gao W, Mostafa NM, Noertersheuser P, Chiuve SE, Owens C, Shebley M. Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women. Clin Transl Sci. 2021 Jul;14(4):1452-1463. doi: 10.1111/cts.13006. Epub 2021 Apr 8.'}, {'pmid': '31971678', 'type': 'DERIVED', 'citation': 'Schlaff WD, Ackerman RT, Al-Hendy A, Archer DF, Barnhart KT, Bradley LD, Carr BR, Feinberg EC, Hurtado SM, Kim J, Liu R, Mabey RG Jr, Owens CD, Poindexter A, Puscheck EE, Rodriguez-Ginorio H, Simon JA, Soliman AM, Stewart EA, Watts NB, Muneyyirci-Delale O. Elagolix for Heavy Menstrual Bleeding in Women with Uterine Fibroids. N Engl J Med. 2020 Jan 23;382(4):328-340. doi: 10.1056/NEJMoa1904351.'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '51 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is a premenopausal female at the time of Screening.\n* Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound).\n* Subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by menstrual blood loss \\> 80 mL during each of two screening menses as measured by the alkaline hematin method.\n* Subject has negative urine and/or serum pregnancy test in Screening and just prior to first dose.\n* Subject has an adequate endometrial biopsy performed during Screening, the results of which show no clinically significant endometrial pathology.\n\nExclusion Criteria:\n\n* Subject has screening pelvic ultrasound or saline infusion sonohysterography results that show a clinically significant gynecological disorder.\n* Subject has history of osteoporosis or other metabolic bone disease.\n* Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.\n* Subject has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).\n* Subject is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.'}, 'identificationModule': {'nctId': 'NCT02691494', 'briefTitle': 'Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women', 'orgStudyIdInfo': {'id': 'M12-817'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/ NETA) once daily (QD)', 'interventionNames': ['Drug: Placebo for Estradiol/Norethindrone Acetate', 'Drug: Placebo for Elagolix']}, {'type': 'EXPERIMENTAL', 'label': 'Elagolix', 'description': 'Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD', 'interventionNames': ['Drug: Elagolix', 'Drug: Placebo for Estradiol/Norethindrone Acetate']}, {'type': 'EXPERIMENTAL', 'label': 'Elagolix + E2/NETA', 'description': 'Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD', 'interventionNames': ['Drug: Elagolix', 'Drug: Estradiol/Norethindrone Acetate']}], 'interventions': [{'name': 'Elagolix', 'type': 'DRUG', 'otherNames': ['ABT-620', 'elagolix sodium'], 'description': 'Film-coated tablets', 'armGroupLabels': ['Elagolix', 'Elagolix + E2/NETA']}, {'name': 'Placebo for Estradiol/Norethindrone Acetate', 'type': 'DRUG', 'description': 'Placebo capsules', 'armGroupLabels': ['Elagolix', 'Placebo']}, {'name': 'Estradiol/Norethindrone Acetate', 'type': 'DRUG', 'otherNames': ['E2/NETA'], 'description': 'Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.', 'armGroupLabels': ['Elagolix + E2/NETA']}, {'name': 'Placebo for Elagolix', 'type': 'DRUG', 'description': 'Film-coated placebo tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235-3430', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC /ID# 152258', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36303', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Choice Research, LLC /ID# 150988', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '36532', 'city': 'Fairhope', 'state': 'Alabama', 'country': 'United States', 'facility': 'Brown, Pearson, Guepet Gynecology /ID# 151020', 'geoPoint': {'lat': 30.52297, 'lon': -87.90333}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 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{'zip': '99352', 'city': 'Richland', 'state': 'Washington', 'country': 'United States', 'facility': 'Zain Research /ID# 151018', 'geoPoint': {'lat': 46.28569, 'lon': -119.28446}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center /ID# 149758', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'P3A 1W8', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Medicor Research Inc. /ID# 153406', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'N8W 5R7', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Victory Reproductive Care /ID# 150247', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}