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

January 23, 2019 updated by: Repros Therapeutics Inc.

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

ZPE-201 Extension of treatment

Study Overview

Status

Terminated

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Advanced Clinical Therapeutics, LLC
    • California
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
      • San Ramon, California, United States, 94583
        • Compass Clinical Research
    • Florida
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Physicians for Women
    • Ohio
      • Miamisburg, Ohio, United States, 45322
        • HWC Women's Research Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas/Institute for Women's Health
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas/Seven Oaks Women's Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proellex®
25 mg Proellex®
Drug: Proellex®
one (1) 25 mg capsule daily
Other Names:
  • CDB-4124

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Repros Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2009

Primary Completion (Actual)

August 31, 2009

Study Completion (Actual)

August 31, 2009

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 12, 2009

First Posted (Estimate)

August 13, 2009

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZPE-201 EXT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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