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

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

Outcome

Met primary endpoint

registry analysis (superiority test); Telapristone Acetate 6 mg vs Placebo; p = 0.0008; Chi-Square Test NCT02301897 ↗

registry analysis (superiority test); Telapristone Acetate 12 mg vs Placebo; p <0.001; Chi-Square Test NCT02301897 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Proellex	Other / unclassified	6 mg	Oral
Subject	Proellex	Other / unclassified	12 mg	Oral

Indications