Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
Study NCT ID:
NCT01069094
Status:
COMPLETED
Last Update Posted:
2014-06-30
First Post:
2010-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}, {'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C461063', 'term': 'telapristone acetate'}, {'id': 'D016729', 'term': 'Leuprolide'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-27', 'studyFirstSubmitDate': '2010-02-12', 'studyFirstSubmitQcDate': '2010-02-16', 'lastUpdatePostDateStruct': {'date': '2014-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Determine the tolerability of three doses of Progenta (12.5 mg, 25 mg, and 50 mg) as compared to placebo and Lucron Depot (leuprolide acetate for depot suspension) in pre-menopausal women with symptomatic leiomyomata.', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Uterine fibroids'], 'conditions': ['Uterine Leiomyomata']}, 'descriptionModule': {'briefSummary': 'A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.', 'detailedDescription': 'Three doses of Progenta (CDB4124 - 12.5, 25, 50 mg) versus placebo versus Lucron Depot (leuprolide acetate for depot suspension) was initiated in females with symptomatic leiomyomata. A single dose PK visit was conducted only for subjects randomized to the Progenta arm, between screening and visit 1. A second PK assessment was conducted at Visit 3 (one month on drug) to collect steady state data. Treatment period lasted for 3 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had at least one leiomyomata lesion that was identifiable and measurable by transvaginal ultrasound.\n* Had a regular or steady menstrual cycle lasting from 24 to 36 days.\n\nExclusion Criteria:\n\n* Post-menopausal\n* Subject with documented endometriosis'}, 'identificationModule': {'nctId': 'NCT01069094', 'briefTitle': 'A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata', 'organization': {'class': 'INDUSTRY', 'fullName': 'Repros Therapeutics Inc.'}, 'officialTitle': 'A Single Dose lead-in PK Followed by a Randomized, Double-blinded, Controlled, Multiple Dose Study of the Selective Progesterone Receptor Modulator Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata', 'orgStudyIdInfo': {'id': 'ZN-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'progenta 12.5 mg', 'description': 'Progenta (CDB-4124) 12.5 mg capsule', 'interventionNames': ['Drug: Progenta']}, {'type': 'EXPERIMENTAL', 'label': 'progenta 25 mg', 'description': 'Progenta (CDB-4124) 25 mg capsule', 'interventionNames': ['Drug: Progenta']}, {'type': 'EXPERIMENTAL', 'label': 'progenta 50 mg', 'description': 'Progenta (CDB-4124) 50 mg capsule', 'interventionNames': ['Drug: Progenta']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lucron Depot', 'description': 'Lucron Depot, Leuprolide acetate for depot suspension', 'interventionNames': ['Drug: Lucron Depot']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo capsule', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Progenta', 'type': 'DRUG', 'otherNames': ['CDB-4124', 'Telapristone acetate'], 'description': '12.5 mg, administered as a once daily oral dose for 90 days.', 'armGroupLabels': ['progenta 12.5 mg']}, {'name': 'Progenta', 'type': 'DRUG', 'otherNames': ['CDB-4124', 'Telapristone acetate'], 'description': '25 mg, administered as a once daily oral dose for 90 days.', 'armGroupLabels': ['progenta 25 mg']}, {'name': 'Progenta', 'type': 'DRUG', 'otherNames': ['CDB-4124'], 'description': '50 mg, administered as a once daily oral dose for 90 days.', 'armGroupLabels': ['progenta 50 mg']}, {'name': 'Lucron Depot', 'type': 'DRUG', 'otherNames': ['leuprolide acetate for depot suspension'], 'description': '3.75 mg IM monthly', 'armGroupLabels': ['Lucron Depot']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered as a once daily oral dose for 90 days.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-106', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Medical University /MTZ Clinical Research Sp.zo.o.', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Ronald Wiehle, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Repros Therapeutics Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Repros Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}