A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Status: Active
Purpose: To determine the safety and efficacy of two oral doses of Proellex in premenopausal women with symptomatic uterine fibroids confirmed by MRI.
Eligibility:
- Is a pre-menopausal female, 18-47
- Subject has a history of at least 3 regular menstrual cycles in which menorrhagia (heavy bleeding) is due to uterine fibroids
- Confirmed uterine fibroid(s) at screening
Study Drug: Proellex® 6mg and 12mg oral capsules, matching placebo
Study Design: Treatment, Double-Blind, Safety
Primary Outcome Measures:
- Amenorrhea [ Time Frame: 18 weeks of treatment ] [ Designated as safety issue: No ]
- Percentage of subjects who become amenorrheic after one course of treatment
For more information, please visit www.clinicaltrials.gov. If you meet the study criteria and are interested in participating, please contact:
Study Director:
Repros Therapeutics Inc.
800-895-6554ext 3401
StudyInfo@reprosrx.com
Clinical Site Locations:
Alabama
Birmingham
Arizona
Phoenix
Florida
Ft. Lauderdale
South Carolina
Summerville
Tennessee
Jackson
Knoxville
Texas
Dallas
Houston