Clinical Trials

A Phase 2, Multi-Center, Three-Arm, 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 Endometriosis

Status: Active

Purpose: To determine the safety and efficacy of two doses of Proellex in premenopausal women with pelvic pain in endometriosis confirmed within the last seven years and using prescription analgesics for symptomatic pain.

Eligibility:

  • Females, ages 18 to 47 years
  • Uterine fibroids confirmed by ultrasound. Normal or abnormal; but, non-clinically significant, transvaginal ultrasound.
  • History of menstrual events occurring in regular cycles.

Study Drug: Proellex® 6 mg and 12mg oral capsules, matching placebo

Study Design: Treatment, Double-Blind, Safety

Primary Outcome Measures:

  • Change and percent change in the individual Biberoglu & Behrman Symptom Severity (BBSS) scores

Secondary Outcome Measures:

  • Change in daily average use and percent change of prescription analgesics
  • Change in daily average use and percent change of over the counter analgesics
  • Change in daily average use and percent change of overall analgesic use
  • Change from baseline in pain assessed using a Visual Analog Scale (VAS)
  • Change from baseline in daily average dysmenorrhea and non-menstrual pelvis pain using an 11-point numerical rating scale (NRS)

For more information, please visit www.clinicaltrials.gov or contact:

Study Director:
Repros Therapeutics Inc.
800-895-6554ext 3401
StudyInfo@reprosrx.com

Clinical Site Locations:

Arkansas
Little Rock

Florida
Jacksonville
Margate

South Carolina
Summerville

Texas
Houston

Utah
Riverton
Salt Lake City

Virgina
Richmond

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