Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids

Summary

The primary objective of this study is to determine the safety and efficacy of two vaginal 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

2015-02-12

Primary completion

2017-04-06

Completion

2017-04-06

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Telapristone Acetate 6 mg; p = 0.0019; Fisher Exact NCT02323646 ↗

registry analysis (superiority test); Placebo vs Telapristone Acetate 12 mg; p = 0.0063; Fisher Exact NCT02323646 ↗

Drugs

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

Indications