NCT01728454

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

A Phase 2, Multi-Center, Three-Arm, 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 Endometriosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 47 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a phase 2, 3-arm-study with an 18-week active dosing period and an option for participants to receive 2 additional 16-week cycles of active treatment at their randomized dose \[6 mg or 12 mg/day\]. Placebo participants who elect additional treatment will receive treatment at 12 mg/day. The treatment dose will remain double-blind. The study will be conducted in 3 stages. The first stage is a no treatment baseline assessment period. This stage will last as long as it takes to record at least one full menstrual cycle (ovulation until ovulation). For stage 2, following the run-in stage, at Visit 3, 60 participants will be randomized into one of 3 arms in a 1-1-1 fashion. The start of dosing should commence as soon as possible after ovulation following the end of the previous menstrual event. For stage 3, participants who are eligible to receive additional cycles of treatment and who elect to continue treatment will be scheduled within a week before the second expected menses (+/- 2 days), following the off-drug interval. Participants will receive 2 cycles of treatment separated by an off-drug interval (ODI), after which they will be followed until menses has returned.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo matching capsules, orally, once daily for 18 weeks.
DRUG	Telapristone acetate	Telapristone acetate capsules, orally once daily for 18 weeks.

Timeline

• Start date: 2013-05-02
• Primary completion: 2017-03-15
• Completion: 2017-03-15
• First posted: 2012-11-19
• Last updated: 2019-07-23
• Results posted: 2019-07-23

Locations

10 sites across 1 country: United States