NCT00735553

Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids

A Phase III, Three-arm, Parallel Design, Placebo-controlled, Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

Detailed description

Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Proellex	One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months
DRUG	Proellex	Two 25 mg mg capsules of Proellex® orally daily for up to four months
DRUG	Placebo	Two placebo capsules orally daily for up to four months

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-08-15
• Last updated: 2014-08-21
• Results posted: 2014-08-21

Locations

15 sites across 1 country: United States