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

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

Outcome

Mixed primary results

registry MEAN Telapristone Acetate 6 mg: Change from Baseline to On-Drug Cycle 1: -8.46 (Standard Deviation 5.174) score on a scale per 28-day period NCT01728454 ↗

registry MEAN Placebo: Change from Baseline to On-Drug Cycle 1: -3.95 (Standard Deviation 5.936) score on a scale per 28-day period NCT01728454 ↗

registry analysis (superiority test); Placebo vs Telapristone Acetate 6 mg; p = 0.0360; Wilcoxon Rank- Sum Test NCT01728454 ↗

registry analysis (superiority test); Placebo vs Telapristone Acetate 6 mg; p = 0.1017; Wilcoxon Rank- Sum Test NCT01728454 ↗

registry analysis (superiority test); Placebo vs Telapristone Acetate 6 mg; p = 0.7508; Wilcoxon Rank- Sum Test NCT01728454 ↗

Publications

• Rolla E. Endometriosis: advances and controversies in classification, pathogenesis, diagnosis, and treatment. F1000Res. 2019 Apr 23;8:F1000 Faculty Rev-529. doi: 10.12688/f1000research.14817.1. eCollection 2019.

Drugs

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

Indications