A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Purpose: To determine the safety of extended treatment with Proellex in women who have successfully completed either study ZPV-201 or ZPU-203 and meet eligibility criteria.
- Is a pre-menopausal female, 18-47
- Completed either study ZPV-201 or ZPU-203
Study Drug: Proellex® 12mg oral capsules
Study Design: Treatment, double-blind, safety
Primary Outcome Measures:
- Amenorrhea [ Time Frame: 13 months ] [ Designated as safety issue: No ] Percentage of subjects who become amenorrheic after one course of treatment
- Change in UFS-QOL Symptom Severity score comparing to the previous study baseline and study baseline [ Time frame: 13 months] [ Designated as safety issue: No ]
- Change in the individual UFS-QOL sub scores [ Time frame: 13 months ] [ Designated as safety issue: No ]
- Change in PBAC scores [ Time frame: 13 months ] [ Designated as safety issue: No ]
- Percentage change from parent study baseline and study baseline in total uterine fibroid volume measured by MRI [ Time frame: 13 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: