NCT00882258

Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.

Detailed description

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	12.5 mg Proellex	12.5 mg Proellex administered orally daily
DRUG	25 mg Proellex	25 mg Proellex administered orally daily
DRUG	Placebo	Administered orally daily

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2009-04-16
• Last updated: 2014-07-08

Locations

16 sites across 1 country: United States