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
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.
- 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:
Repros Therapeutics Inc.
Clinical Site Locations:
Salt Lake City