Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT00290251
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2006-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555622', 'term': 'ulipristal acetate'}, {'id': 'C094854', 'term': 'ulipristal'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'NiemanL@nih.gov', 'phone': '301-496-8935', 'title': 'Lynnette Nieman MD', 'organization': 'NICHD, NIH'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '120 - 132 days', 'description': 'Women recorded specific adverse events on a calendar; there was also a write-in field. The number of women with at least one day of each symptom is reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Ulipristal Acetate -20mg', 'description': 'Women received ulipristal acetate at a daily dose of 20 mg for 90 - 102 days or three menstrual cycles.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 11, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ulipristal Acetate- 10 mg', 'description': 'Women received ulipristal acetate at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Women received placebo capsules for 90 - 102 days or three menstrual cycles.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 12, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Pre-Ulipristal Acetate 20 mg', 'description': 'Women charted symptoms for one menstrual cycle before entering ulipristal acetate 20 mg group', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 10, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Pre-Ulipristal Acetate- 10 mg', 'description': 'Women charted symptoms for one menstrual cycle before entering ulipristal acetate 10 mg group', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Pre-Placebo', 'description': 'Women charted symptoms for one menstrual cycle before entering placebo group', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 10, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 69, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 50, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 64, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 21, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 13, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 8, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/vomiting', 'notes': 'Self-reported via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flashes', 'notes': 'Self-reported via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 14, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 64, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-menses Vaginal Bleeding', 'notes': 'self-assessed via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 107, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 12, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 40, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast pain', 'notes': 'self-assessed via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 25, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 95, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 44, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 20, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 14, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 10, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'notes': 'self-assessed via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 110, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 37, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 77, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 29, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 33, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 32, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic pain', 'notes': 'Self-assessed via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 16, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 16, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 23, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 23, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 14, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'self-assessed via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 25, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 195, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 75, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 31, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 76, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 40, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetitie', 'notes': 'self-assessed via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'notes': 'self-assessed via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint Pain', 'notes': 'self-assessed via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 33, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 40, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 11, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Calf or Thigh pain', 'notes': 'self-assessed via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 19, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'self-assessed via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 36, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 24, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal cramps', 'notes': 'self-assessed via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mood changes', 'notes': 'self-assessed via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 16, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'notes': 'self-assessed via calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg swelling', 'notes': 'self-assessed via calendar and write-in option', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased appetite', 'notes': 'self-assessed via calendar using write-in option', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'notes': 'self-assessed by calendar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 20, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depersonalization', 'notes': 'Out of body experience', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 43, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'blood clots with menses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 15, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower extremity edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 76, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'constipaton', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'blurry vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hair loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cold feet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'galactorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'food cravings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'breast engorgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'disrupted sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Shrinkage of Fibroids - Size of Fibroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulipristal Acetate -20mg', 'description': 'Women received ulipristal acetate at 20 mg/day for 90 - 102 days or three menstrual cycles.'}, {'id': 'OG001', 'title': 'Ulipristal Acetate - 10 mg', 'description': 'Women received ulipristal acetate at 10 mg/day for 90 - 102 days or three menstrual cycles.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Women received placebo capsules for 90 - 102 days or three menstrual cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.07', 'spread': '0.78', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'performed on log-transformed delta change in total fibroid volume from baseline to end of treatment'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Ulipristal acetate groups one and two were first compared and found to be similar (see statistical analysis 1), so they were combined into a single treatment group for comparison to placebo group', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Performed on log-transformed delta change'}], 'paramType': 'MEAN', 'timeFrame': '3 months (baseline to end of treatment)', 'description': 'The primary outcome, fibroid volume, was calculated by an ellipsoid formula (π/6xd1xd2xd3) using orthogonal three-dimensional measurements taken from pelvic MRI scan. Individual volumes were summed to assess total fibroid volume for each woman, which were log-transformed before analysis. Women with paired MRI results were included in this intent to treat analysis, even if they did not take all study medication. Fibroids were included if they were seen on both studies.The absolute change in cm3 between baseline and end of treatment was calculated and its log was used for statistics and reporting the results in the data table below.', 'unitOfMeasure': 'logcm3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, including women with two MRIs regardless of whether they took all study medication. The two ulipristal acetate arms, 10 mg and 20 mg, were not different from each other (see statistical analysis 1) so they were combined for analysis of outcomes (in statistical analysis 2).'}, {'type': 'SECONDARY', 'title': 'Short Form-36 and Uterine Fibroid Symptom Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulipristal Acetate -10 and 20mg', 'description': 'Women received ulipristal acetate at a daily dose of 10 or 20 mg for 90 - 102 days or three menstrual cycles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women received placebo capsules for 90 - 102 days or three menstrual cycles.'}], 'classes': [{'title': 'SF-36 Physical Component', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 Mental Component', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'UFS Symptom Severity Score', 'categories': [{'measurements': [{'value': '-28.3', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'UFS Overall health related quality of life', 'categories': [{'measurements': [{'value': '27.8', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'UFS Concern subscore', 'categories': [{'measurements': [{'value': '46.1', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'UFS Energy/mood subscore', 'categories': [{'measurements': [{'value': '19.2', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '5.8', 'groupId': 'OG001'}]}]}, {'title': 'UFS Control subscore', 'categories': [{'measurements': [{'value': '20.3', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'UFS self-conscious subscore', 'categories': [{'measurements': [{'value': '19.0', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'UFS sexual function subscore', 'categories': [{'measurements': [{'value': '25.7', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'UFS activities subscore', 'categories': [{'measurements': [{'value': '83.9', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '56.1', 'spread': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'UFS composite bleeding subscore', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'The Delta of scores from treatment end to baseline was used to compare by ANOVA.', 'groupDescription': 'No sample size calculation was made.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Adjustment for age'}], 'paramType': 'MEAN', 'timeFrame': '3 months (Baseline to end of treatment 1)', 'description': 'The short form-36 (SF-36)and Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaires were given before and at treatment end with scales of 0 - 100. SF-36 scales = mental and physical well-being. The UFS subscales are symptom severity, concern, activities, energy and mood, control, self-consciousness, sexual functioning compiled into an overall QOL score. Higher results indicate better QOL on all but symptom severity (higher = worse). The change in scores from baseline to end of treatment was calculated.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All completers received a questionnaire at the end of the three-month study. One woman in the placebo group did not complete the questionnaire. All women receiving ulipristal acetate were combined for analysis of QOL, to parallel the combined analysis done for the primary outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pre-ulipristal Acetate - 20 mg', 'description': 'Women received no intervention for one menstrual cycle before entering ulipristal acetate 20 mg group'}, {'id': 'FG001', 'title': 'Pre-ulipristal Acetate 10 mg', 'description': 'Women received no intervention for one menstrual cycle before entering ulipristal acetate 20 mg group'}, {'id': 'FG002', 'title': 'Pre-placebo', 'description': 'Women received no intervention for one menstrual cycle before entering placebo group'}, {'id': 'FG003', 'title': 'Ulipristal Acetate - 20 mg', 'description': 'Women received ulipristal acetate 20 mg/d'}, {'id': 'FG004', 'title': 'Ulipristal Acetate- 10 mg', 'description': 'Women received ulipristal acetate at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.'}, {'id': 'FG005', 'title': 'Placebo (PLC)', 'description': 'Women received placebo capsules for 90 - 102 days or three menstrual cycles.'}], 'periods': [{'title': 'Baseline (Month 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment 1 (Months 2-4)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Subjects crossed over from no intervention baseline to treatment assignment', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Subjects crossed over from no intervention baseline to treatment assignment', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Subjects crossed over from no intervention baseline to treatment assignment', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Subjects crossed over from no intervention baseline to treatment assignment', 'groupId': 'FG003', 'numSubjects': '14'}, {'comment': 'Subjects crossed over from no intervention baseline to treatment assignment', 'groupId': 'FG004', 'numSubjects': '14'}, {'comment': 'Subjects crossed over from no intervention baseline to treatment assignment', 'groupId': 'FG005', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'headache', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Out of body experience', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Seventy-two women were screened for eligibility before being randomized to treatment. Of these only 42 were eligible to continue in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'All women who received placebo'}, {'id': 'BG001', 'title': 'Ulipristal Acetate 10 mg', 'description': 'All women who received Ulipristal Acetate - 20 mg'}, {'id': 'BG002', 'title': 'Ulipristal Acetate 20 mg', 'description': 'All women who received Ulipristal Acetate - 20 mg'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '42', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'study agents were formulated in identical looking capsules'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects were studied during a single baseline menstrual cycle followed by a cross-over into three arms (active treatment at one of two doses, or placebo) given for three menstrual cycles'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2006-02-10', 'resultsFirstSubmitDate': '2011-10-28', 'studyFirstSubmitQcDate': '2006-02-09', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-11-14', 'studyFirstPostDateStruct': {'date': '2006-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shrinkage of Fibroids - Size of Fibroids', 'timeFrame': '3 months (baseline to end of treatment)', 'description': 'The primary outcome, fibroid volume, was calculated by an ellipsoid formula (π/6xd1xd2xd3) using orthogonal three-dimensional measurements taken from pelvic MRI scan. Individual volumes were summed to assess total fibroid volume for each woman, which were log-transformed before analysis. Women with paired MRI results were included in this intent to treat analysis, even if they did not take all study medication. Fibroids were included if they were seen on both studies.The absolute change in cm3 between baseline and end of treatment was calculated and its log was used for statistics and reporting the results in the data table below.'}], 'secondaryOutcomes': [{'measure': 'Short Form-36 and Uterine Fibroid Symptom Quality of Life', 'timeFrame': '3 months (Baseline to end of treatment 1)', 'description': 'The short form-36 (SF-36)and Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaires were given before and at treatment end with scales of 0 - 100. SF-36 scales = mental and physical well-being. The UFS subscales are symptom severity, concern, activities, energy and mood, control, self-consciousness, sexual functioning compiled into an overall QOL score. Higher results indicate better QOL on all but symptom severity (higher = worse). The change in scores from baseline to end of treatment was calculated.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endometrium', 'Progesterone', 'Estrogen', 'Fibroid', 'Hysterectomy', 'Leiomyoma', 'Uterine Fibroids', 'Fibroids'], 'conditions': ['Leiomyoma']}, 'referencesModule': {'references': [{'pmid': '1442957', 'type': 'BACKGROUND', 'citation': 'Batista MC, Cartledge TP, Zellmer AW, Merino MJ, Axiotis C, Loriaux DL, Nieman LK. Delayed endometrial maturation induced by daily administration of the antiprogestin RU 486: a potential new contraceptive strategy. Am J Obstet Gynecol. 1992 Jul;167(1):60-5. doi: 10.1016/s0002-9378(11)91627-5.'}, {'pmid': '11786376', 'type': 'BACKGROUND', 'citation': 'Burroughs KD, Howe SR, Okubo Y, Fuchs-Young R, LeRoith D, Walker CL. Dysregulation of IGF-I signaling in uterine leiomyoma. J Endocrinol. 2002 Jan;172(1):83-93. doi: 10.1677/joe.0.1720083.'}, {'pmid': '9046951', 'type': 'BACKGROUND', 'citation': 'Cadepond F, Ulmann A, Baulieu EE. RU486 (mifepristone): mechanisms of action and clinical uses. Annu Rev Med. 1997;48:129-56. doi: 10.1146/annurev.med.48.1.129.'}, {'pmid': '19268886', 'type': 'BACKGROUND', 'citation': 'Levens ED, Wesley R, Premkumar A, Blocker W, Nieman LK. Magnetic resonance imaging and transvaginal ultrasound for determining fibroid burden: implications for research and clinical care. Am J Obstet Gynecol. 2009 May;200(5):537.e1-7. doi: 10.1016/j.ajog.2008.12.037. Epub 2009 Mar 9.'}, {'pmid': '21055739', 'type': 'BACKGROUND', 'citation': 'Nieman LK, Blocker W, Nansel T, Mahoney S, Reynolds J, Blithe D, Wesley R, Armstrong A. Efficacy and tolerability of CDB-2914 treatment for symptomatic uterine fibroids: a randomized, double-blind, placebo-controlled, phase IIb study. Fertil Steril. 2011 Feb;95(2):767-72.e1-2. doi: 10.1016/j.fertnstert.2010.09.059. Epub 2010 Nov 5.'}, {'pmid': '32033718', 'type': 'DERIVED', 'citation': 'Parikh TP, Malik M, Britten J, Aly JM, Pilgrim J, Catherino WH. Steroid hormones and hormone antagonists regulate the neural marker neurotrimin in uterine leiomyoma. Fertil Steril. 2020 Jan;113(1):176-186. doi: 10.1016/j.fertnstert.2019.08.090.'}, {'pmid': '30871768', 'type': 'DERIVED', 'citation': 'Lewis TD, Malik M, Britten J, Parikh T, Cox J, Catherino WH. Ulipristal acetate decreases active TGF-beta3 and its canonical signaling in uterine leiomyoma via two novel mechanisms. Fertil Steril. 2019 Apr;111(4):806-815.e1. doi: 10.1016/j.fertnstert.2018.12.026. Epub 2019 Mar 11.'}, {'pmid': '30239831', 'type': 'DERIVED', 'citation': 'Ng SSM, Jorge S, Malik M, Britten J, Su SC, Armstrong CR, Brennan JT, Chang S, Baig KM, Driggers PH, Segars JH. A-Kinase Anchoring Protein 13 (AKAP13) Augments Progesterone Signaling in Uterine Fibroid Cells. J Clin Endocrinol Metab. 2019 Mar 1;104(3):970-980. doi: 10.1210/jc.2018-01216.'}, {'pmid': '18448745', 'type': 'DERIVED', 'citation': 'Levens ED, Potlog-Nahari C, Armstrong AY, Wesley R, Premkumar A, Blithe DL, Blocker W, Nieman LK. CDB-2914 for uterine leiomyomata treatment: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1129-36. doi: 10.1097/AOG.0b013e3181705d0e.'}], 'seeAlsoLinks': [{'url': 'http://clinicalstudies.info.nih.gov/detail/B_2006-CH-0090.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.', 'detailedDescription': 'Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in pre-menopausal women that may cause bleeding, pelvic pain and pressure. Because fibroids grow in the presence of estrogen, medical therapies that decrease estrogen levels (like Gonadotropin releasing hormone,GnRH analog) cause fibroids to shrink and so may relieve symptoms. However, such medication can only be given short-term and has inconvenient side effects such as hot-flashes. Thus, many women with symptomatic fibroids choose to have them removed surgically, either individually or by removing the uterus via hysterectomy.\n\nWomen between 25 and 50 years of age who have regular menstrual cycles and a history of uterine fibroids that cause heavy bleeding, pressure, or pain may be eligible for this study. Candidates are screened with a medical history and physical examination, including breast and pelvic examination, blood and urine tests, a quality-of-life questionnaire, and a home urine test for leuteinizing hormone (LH) surge. They are given a diary to record the LH surge, days of vaginal spotting or bleeding, and symptoms. Participation includes the following:\n\nBaseline Studies (First Menstrual Cycle)\n\n* Magnetic resonance imaging (MRI): The subject lies in the MRI scanner, a narrow cylinder with a strong magnetic field, for imaging the uterus.\n* Saline hysterosonogram: This is an ultrasound examination of the uterus. A speculum is placed in the vagina and a small amount of liquid is inserted into the uterus. A probe is then inserted into the vagina. The probe emits and receives sound waves that are used to visualize the fibroids and surrounding structures.\n\nStudy Drug Phase (Second through Fourth Menstrual Cycles)\n\n* Subjects are randomly assigned to take ulipristal acetate or placebo (inactive compound) once a day by mouth on an empty stomach for three menstrual cycles or up to 102 days if menstrual cycles are irregular or stop.\n* Pregnancy test on first or second day of every menstrual cycle.\n* Blood tests every 2 weeks to measure effects of study medication on hormones, blood count, blood chemistries and liver function.\n* 24-hour urine collections three times during the study, about once a month, to measure cortisol and check adrenal gland function.\n* Repeat transvaginal ultrasound after 4-6 weeks of study drug to check fibroid growth.\n* Repeat hysterosonogram and MRI within 2 weeks of surgery to count and measure the fibroids. or placebo (inactive compound) once a day by mouth on an empty stomach for three menstrual cycles or up to 102 days if menstrual cycles are irregular or stop.\n* Pregnancy test on first or second day of every menstrual cycle.\n* Blood tests every 2 weeks to measure effects of study medication on hormones, blood count, blood chemistries and liver function.\n* 24-hour urine collections three times during the study, about once a month, to measure cortisol and check adrenal gland function.\n* Repeat transvaginal ultrasound after 4-6 weeks of study drug to check fibroid growth.\n* Repeat hysterosonogram and MRI within 2 weeks of surgery to count and measure the fibroids. or placebo (inactive compound) once a day by mouth on an empty stomach for three menstrual cycles or up to 102 days if menstrual cycles are irregular or stop.\n* Pregnancy test on first or second day of every menstrual cycle.\n* Blood tests every 2 weeks to measure effects of study medication on hormones, blood count, blood chemistries and liver function.\n* 24-hour urine collections three times during the study, about once a month, to measure cortisol and check adrenal gland function.\n* Repeat transvaginal ultrasound after 4-6 weeks of study drug to check fibroid growth.\n* Repeat hysterosonogram and MRI within 2 weeks of surgery to count and measure the fibroids.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Female gender-to evaluate effects in the target population for clinical trials.\n* History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the American College of Obstetrics and Gynecology (ACOG) practice bulletin:\n* Excessive uterine bleeding will be evidenced by either of the following-profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days; or anemia due to acute or chronic blood loss;\n\nOR\n\n* Pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower abdominal or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection.\n* Uterine leiomyoma(ta) of at least 2 cm size.\n* In good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at the discretion of the research team. Interval use of over-the-counter drugs is acceptable but must be recorded.\n* Menstrual cycles of 24 - 35 days.\n* Hemoglobin greater than 10 g/dL (for those wishing surgery); iron may be administered to improve red blood cell counts.\n* Willing and able to comply with study requirements.\n* Age 25 to 50.\n* Using mechanical (condoms, diaphragms) sterilization or abstinence methods of contraception for the duration of the study.\n* Negative urine pregnancy test.\n* Body mass index (BMI) less than or equal to 33, if a surgical candidate or less than or equal to 35, if not a surgical candidate.\n* Creatinine less than 1.3 mg/dL.\n* Liver function tests within 130% of upper limit.\n* If interested in hysterectomy, no desire for fertility.\n\nEXCLUSION CRITERIA:\n\n* Significant abnormalities in the history, physical or laboratory examination.\n* Pregnancy.\n* Lactation.\n* Use of oral, injectable or inhaled glucocorticoids or megestrol within the last year.\n* Unexplained vaginal bleeding.\n* History of malignancy within the past 5 years.\n* Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations.\n* Use of agents known to induce hepatic P450 enzymes; use of imidazoles.\n* Current use of Gonadotropin-releasing hormone (GnRH) analogs or other compounds that affect menstrual cyclicity.\n* Follicle stimulating hormone (FSH) greater than 20 IU/mL.\n* Untreated cervical dysplasia.\n* Need for interval use of narcotics.\n* Abnormal adnexal/ovarian mass.\n* Use of herbal medication having estrogenic or antiestrogenic effects within the past 3 months.\n* Contradiction to anesthesia, for women planning surgery.\n* Genetic causes of leiomyomata.\n* Previous participation in the study.\n* Known recent rapid growth of fibroids, defined as a doubling in size in six months.'}, 'identificationModule': {'nctId': 'NCT00290251', 'briefTitle': 'Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Shrink Leiomyomata', 'orgStudyIdInfo': {'id': '060090'}, 'secondaryIdInfos': [{'id': '1ZIAHD000637-17', 'link': 'https://reporter.nih.gov/quickSearch/1ZIAHD000637-17', 'type': 'NIH'}, {'id': '06-CH-0090', 'type': 'OTHER', 'domain': 'NIH IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ulipristal acetate -20 mg', 'description': '20 mg daily dose ulipristal acetate for three menstrual cycles or up to 102 days', 'interventionNames': ['Drug: ulipristal acetate 20 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ulipristal acetate - 10 mg', 'description': '10 mg daily dose ulipristal acetate for three menstrual cycles or up to 102 days', 'interventionNames': ['Drug: ulipristal acetate 10 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo taken daily for three menstrual cycles or up to 102 days', 'interventionNames': ['Drug: placebo']}, {'type': 'NO_INTERVENTION', 'label': 'Pre-ulipristal acetate 10 mg', 'description': 'Subjects were studied during one baseline cycle without any intervention before entering ulipristal acetate 10 mg arm'}, {'type': 'NO_INTERVENTION', 'label': 'Pre-ulipristal acetate 20 mg', 'description': 'Subjects were studied during one baseline cycle without any intervention before entering ulipristal acetate 20 mg arm'}, {'type': 'NO_INTERVENTION', 'label': 'Pre-placebo', 'description': 'Subjects were studied during one baseline cycle without any intervention before entering placebo arm'}], 'interventions': [{'name': 'ulipristal acetate 20 mg', 'type': 'DRUG', 'otherNames': ['VA2914; CDB-2914'], 'description': 'ulipristal acetate at a daily dose of 20 mg, given once daily for three menstrual cycles or 90 - 102 days if amenorrheic', 'armGroupLabels': ['ulipristal acetate -20 mg']}, {'name': 'ulipristal acetate 10 mg', 'type': 'DRUG', 'otherNames': ['VA2914; CDB2914'], 'description': '10 mg given daily for three menstrual cycles or 90 - 102 days', 'armGroupLabels': ['ulipristal acetate - 10 mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo given once daily for 3 menstrual cycles or 90 - 102 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20891', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'NIH Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Lynnette K Nieman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NICHD, NIH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'collaborators': [{'name': 'HRA Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}