A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
Phase 1
Completed
- Conditions
- Uterine Leiomyomata
- Interventions
- Registration Number
- NCT01069094
- Lead Sponsor
- Repros Therapeutics Inc.
- Brief Summary
A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 29
Inclusion Criteria
- Had at least one leiomyomata lesion that was identifiable and measurable by transvaginal ultrasound.
- Had a regular or steady menstrual cycle lasting from 24 to 36 days.
Exclusion Criteria
- Post-menopausal
- Subject with documented endometriosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description progenta 12.5 mg Progenta Progenta (CDB-4124) 12.5 mg capsule progenta 25 mg Progenta Progenta (CDB-4124) 25 mg capsule progenta 50 mg Progenta Progenta (CDB-4124) 50 mg capsule Lucron Depot Lucron Depot Lucron Depot, Leuprolide acetate for depot suspension placebo Placebo Placebo capsule
- Primary Outcome Measures
Name Time Method Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata. 90 days
- Secondary Outcome Measures
Name Time Method 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. 90 days
Trial Locations
- Locations (1)
Medical University /MTZ Clinical Research Sp.zo.o.
🇵🇱Warsaw, Poland
Medical University /MTZ Clinical Research Sp.zo.o.🇵🇱Warsaw, Poland