drugset / Trial / NCT02301897

A Multi-Center, 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 Uterine Fibroids

NCT02301897

Phase 2 Completed 43 enrolled Repros Therapeutics Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to determine the safety and efficacy of two oral doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.

Timeline

Start
2015-03-16
Primary completion
2017-06-02
Completion
2017-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Telapristone Acetate Other / unclassified 6 mg Oral
Subject Telapristone Acetate Other / unclassified 12 mg Oral