NCT01961908

Open-Label Extension Study to ZPE-202

A Phase 2, Multi-Center, Open-Label Extension Study to Evaluate the Safety and Efficacy of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Endometriosis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 47 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase 2, open-label extension study of 12 mg Proellex for 2 treatment cycles, each with a 16 week active dosing period. Endometriosis pain, dysmenorrhea, non-menstrual pelvic pain and dyspareunia (BBSS) as well as use of pain medications, and vaginal bleeding intensity will be recorded using an electronic diary and Visual Analog Scale (VAS) pain assessment will be utilized. All subjects will have completed an Off-Drug Interval (ODI) prior to starting treatment. Visit 1 will be scheduled within a week before the next expected menses (+/- 2 days), following the off-drug interval. Subjects will receive 2 cycles of treatment separated by an off-drug interval (ODI), after which they will be followed until menses has returned. During the follow-up period subjects will continue to record study information in the electronic diary. The final follow-up visit will be scheduled after blood flow has stopped.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	Proellex

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-10-14
• Last updated: 2014-02-07

Locations

7 sites across 1 country: United States