Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study

Phase 2

Terminated

• Conditions: Endometriosis
• Interventions: Drug: Proellex®

• Registration Number: NCT00958412
• Lead Sponsor: Repros Therapeutics Inc.

Brief Summary

ZPE-201 Extension of treatment

Detailed Description

This is an extension of the phase II, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of Proellex® was administered once-daily for four (4) months.

Study Timeline

• Study Start: 2009-02-28
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Primary Completion: 2009-08-31
• Study Completion: 2009-08-31
• Results First Submitted: 2014-06-25
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-23
• Last Update Submitted: 2019-01-23
• Results First Posted: 2019-02-12
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

• Only subjects treated in the ZPE-201 study will be allowed to enter the extension study.
• Subjects who withdrew from ZPE-201 due to lack of treatment efficacy will also be invited to participate.

Exclusion Criteria

• All other subjects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proellex®	Proellex®	25 mg Proellex®

Primary Outcome Measures

Name	Time	Method
To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily	6 months	Number of participants who experienced 1 or more adverse event.

Trial Locations

Locations (8)

Clinical Trials of Texas/Institute for Women's Health; 🇺🇸 San Antonio, Texas, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

Comprehensive Clinical Trials; 🇺🇸 West Palm Beach, Florida, United States

Clinical Trials of Texas/Seven Oaks Women's Center; 🇺🇸 San Antonio, Texas, United States

HWC Women's Research Center; 🇺🇸 Miamisburg, Ohio, United States

Physicians for Women; 🇺🇸 Cary, North Carolina, United States

Advanced Clinical Therapeutics, LLC; 🇺🇸 Tucson, Arizona, United States

Compass Clinical Research; 🇺🇸 San Ramon, California, United States