Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids

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.

Timeline

Start

2009-02

Primary completion

2009-08

Completion

2009-08

Outcome

Outcome not reported

Stopped: “Repros stopped the study for safety and FDA put the study on hold for safety.”

Drugs

Indications