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NCT00958412 Clinical Trial

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

Endometriosis Clinical Trial

Official title:
A Randomized, Double-blind Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Premenopausal Women With Symptomatic Endometriosis-extension Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00958412
Other study ID # ZPE-201 EXT
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date February 28, 2009
Est. completion date August 31, 2009

Study information
Verified date January 2019
Source Repros Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ZPE-201 Extension of treatment

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.

Recruitment information / eligibility
Status Terminated
Enrollment 18
Est. completion date August 31, 2009
Est. primary completion date August 31, 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 48 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Proellex®
one (1) 25 mg capsule daily

Locations
Country Name City State
United States Physicians for Women Cary North Carolina
United States HWC Women's Research Center Miamisburg Ohio
United States Clinical Trials of Texas/Institute for Women's Health San Antonio Texas
United States Clinical Trials of Texas/Seven Oaks Women's Center San Antonio Texas
United States Medical Center for Clinical Research San Diego California
United States Compass Clinical Research San Ramon California
United States Advanced Clinical Therapeutics, LLC Tucson Arizona
United States Comprehensive Clinical Trials West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily Number of participants who experienced 1 or more adverse event. 6 months
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