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A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

Phase 1
Completed
Conditions
Uterine Leiomyomata
Interventions
Drug: Lucron Depot
Drug: Placebo
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
GroupInterventionDescription
progenta 12.5 mgProgentaProgenta (CDB-4124) 12.5 mg capsule
progenta 25 mgProgentaProgenta (CDB-4124) 25 mg capsule
progenta 50 mgProgentaProgenta (CDB-4124) 50 mg capsule
Lucron DepotLucron DepotLucron Depot, Leuprolide acetate for depot suspension
placeboPlaceboPlacebo capsule
Primary Outcome Measures
NameTimeMethod
Assess the safety of Progenta when administered in pre-menopausal women with symptomatic leiomyomata.90 days
Secondary Outcome Measures
NameTimeMethod
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

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