Clinical Trial: Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase III, Three-Arm, Parallel Design, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in the Treatment of Premenopaus

Brief Summary: Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

Detailed Summary: Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.
Sponsor: Repros Therapeutics Inc.

Current Primary Outcome: To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC) [ Time Frame: 4 months ]

Original Primary Outcome:

  • To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC) [ Time Frame: 4 months ]
  • To determine the efficacy of 50 mg Proellex® versus placebo in the treatment of subjects with symptomatic uterine fibroids from Baseline to Month 4 as determined by scoring changes in the Uterine Fibroid Symptom Quality of Life (UFS-QOL) severity score. [ Time Frame: 4 months ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Repros Therapeutics Inc.

Dates:
Date Received: February 27, 2009
Date Started: February 2009
Date Completion:
Last Updated: August 5, 2014
Last Verified: August 2014