Clinical Trials

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

Status: Ongoing

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.

Eligibility:

  • 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:

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

Clinical Site Locations:

Florida
Ft. Lauderdale

Georgia
Atlanta

Louisiana
Metairie

North Carolina
Raleigh

Tennessee
Jackson

Texas
Houston

Virginia
Richmond

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