Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT00958893
Status:
TERMINATED
Last Update Posted:
2014-08-25
First Post:
2009-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext
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': 'C461063', 'term': 'telapristone acetate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jwike@reprosrx.com', 'phone': '2817193402', 'title': 'Jennifer Wike', 'organization': 'Repros Therapeutics Inc.'}, 'certainAgreement': {'otherDetails': "Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.'}}, 'adverseEventsModule': {'description': 'No adverse event data is available.', 'eventGroups': [{'id': 'EG000', 'title': '25 mg Proellex', 'description': '25 mg Proellex: one 25 mg capsules', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '25 mg Proellex', 'description': '25 mg Proellex: one 25 mg capsules'}], 'timeFrame': 'three 4 month cycles separated by off-drug intervals', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '25 mg Proellex', 'description': '25 mg Proellex: one 25 mg capsules'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Study prematurely terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '25 mg Proellex', 'description': '25 mg Proellex daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Female'}, {'title': 'Male'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Study prematurely terminated'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Repros stopped the study for safety and FDA put the study on hold for safety.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-08', 'studyFirstSubmitDate': '2009-08-11', 'resultsFirstSubmitDate': '2014-06-25', 'studyFirstSubmitQcDate': '2009-08-12', 'lastUpdatePostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-08', 'studyFirstPostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals.', 'timeFrame': 'three 4 month cycles separated by off-drug intervals'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Uterine fibroids'], 'conditions': ['Uterine Fibroids']}, 'descriptionModule': {'briefSummary': 'An open label, extension study for subjects completing the ZPU-003 Ext 1 study.', 'detailedDescription': 'This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cycles separated by off drug intervals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Four subjects at one site whom have completed ZPU 003 Ext 1 study\n\nExclusion Criteria:\n\n* All other subjects'}, 'identificationModule': {'nctId': 'NCT00958893', 'briefTitle': 'An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext', 'organization': {'class': 'INDUSTRY', 'fullName': 'Repros Therapeutics Inc.'}, 'officialTitle': 'An Open-Label Extension Study Evaluating Safety and Efficacy of Proellex® In Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext', 'orgStudyIdInfo': {'id': 'ZPU-003 Extension 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '25 mg Proellex', 'description': '25 mg Proellex daily', 'interventionNames': ['Drug: 25 mg Proellex']}], 'interventions': [{'name': '25 mg Proellex', 'type': 'DRUG', 'otherNames': ['CDB-4124', 'Proellex'], 'description': 'one 25 mg capsules', 'armGroupLabels': ['25 mg Proellex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Advances in Health, Inc.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Andre van As, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Repros Therapeutics Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Repros Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}