A Phase 2, Study to Evaluate the Safety and Efficacy Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Uterine Fibroids
Purpose: To determine the safety and efficacy of two vaginal doses of Proellex in premenopausal women with symptomatic uterine fibroids confirmed by MRI.
- Otherwise healthy adult females between 18 and 47 years
- Subject must have uterine fibroids
Study Drug: Proellex® 6mg and 12mg vaginal capsules and matching placebo
Study Design: Treatment, Double-Blind, Safety
Primary Outcome Measures:
- Percentage of subjects who become amenorrheic after one course of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
For more information, please visit www.clinicaltrials.gov. If you meet the study criteria and are interested in participating, please contact:
Repros Therapeutics Inc.
Clinical Site Locations: