Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT00882258
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2009-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C461063', 'term': 'telapristone acetate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-03', 'studyFirstSubmitDate': '2009-04-14', 'studyFirstSubmitQcDate': '2009-04-14', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata', 'timeFrame': '91 days'}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata', 'timeFrame': '91 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Uterine fibroids'], 'conditions': ['Uterine Fibroids']}, 'descriptionModule': {'briefSummary': 'Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.', 'detailedDescription': 'Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound.\n* Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain\n\nExclusion Criteria:\n\n* Post-menopausal women, as defined as one or more of the following:\n\n 1. six months or more (immediately prior to Screening visit) without a menstrual period, or\n 2. prior hysterectomy and/or oophorectomy\n* Subjects with documented endometriosis'}, 'identificationModule': {'nctId': 'NCT00882258', 'briefTitle': 'Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids', 'organization': {'class': 'INDUSTRY', 'fullName': 'Repros Therapeutics Inc.'}, 'officialTitle': 'A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata', 'orgStudyIdInfo': {'id': 'ZPU-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '12.5 mg Proellex', 'description': 'Proellex 12.5 mg daily', 'interventionNames': ['Drug: 12.5 mg Proellex']}, {'type': 'EXPERIMENTAL', 'label': '25 mg Proellex daily', 'description': 'Proellex 25 mg', 'interventionNames': ['Drug: 25 mg Proellex']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '12.5 mg Proellex', 'type': 'DRUG', 'otherNames': ['CDB-4124', 'Telapristone acetate'], 'description': '12.5 mg Proellex administered orally daily', 'armGroupLabels': ['12.5 mg Proellex']}, {'name': '25 mg Proellex', 'type': 'DRUG', 'otherNames': ['CDB-4124', 'Telapristone acetate'], 'description': '25 mg Proellex administered orally daily', 'armGroupLabels': ['25 mg Proellex daily']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Dummy'], 'description': 'Administered orally daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85015', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Women's Health Research", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Wellness Centre for Women', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85712', 'city': 'Tuscon', 'state': 'Arizona', 'country': 'United States', 'facility': 'Visions Clinical Research Tuscon'}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Centre for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Women's Health Care, Inc.", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Downtown Women's Health Care", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Visions Clinical Research', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Miami Research Associates, Women's Health Studies", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "Insignia Clinical Research (Tampa Bay Women's Center)", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Caring for Women', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Affiliated Clinical Research, Inc.', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'SC Clinical Research Center', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Advances in Health Inc.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Obstetrical & Gynecolgical Associates, PA (OGA)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Women's Clinical Research Centre", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Andre VanAs, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Repros Therapeutics Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Repros Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}