Clinical Trials

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

2408 Timberloch Place, B-7
The Woodlands, Texas 77380
281-719-3400
281-719-3446 fax