drugset / Trial / NCT01728454

Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis

NCT01728454

Phase 2 Completed 60 enrolled Repros Therapeutics Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of this study is to determine the safety and efficacy of two oral doses of telapristone acetate administered to premenopausal women with pelvic pain associated with endometriosis confirmed within the last seven years and using prescription analgesics for symptomatic pain.

Timeline

Start
2013-05-02
Primary completion
2017-03-15
Completion
2017-03-15

Drugs

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

Indications