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

This study has been terminated.
(Repros stopped the study for safety and FDA put the study on hold for safety.)
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00958412
First received: August 11, 2009
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Endometriosis
Drug: Proellex®
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • To evaluate incidence of adverse events (AEs) and safety of Proellex® administered once daily [ Time Frame: two (2) separate treatment cycles of four (4) months ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proellex®
25 mg Proellex®
Drug: Proellex®
one (1) 25 mg capsule daily
Other Name: CDB-4124

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958412

Locations
United States, Arizona
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, United States, 85712
United States, California
Medical Center for Clinical Research
San Diego, California, United States, 92108
Compass Clinical Research
San Ramon, California, United States, 94583
United States, Florida
Comprehensive Clinical Trials
West Palm Beach, Florida, United States, 33409
United States, North Carolina
Physicians for Women
Cary, North Carolina, United States, 27518
United States, Ohio
HWC Women's Research Center
Miamisburg, Ohio, United States, 45322
United States, Texas
Clinical Trials of Texas/Institute for Women's Health
San Antonio, Texas, United States, 78229
Clinical Trials of Texas/Seven Oaks Women's Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Andre van As, MD, PhD Repros Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00958412     History of Changes
Other Study ID Numbers: ZPE-201 EXT
Study First Received: August 11, 2009
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Endometriosis
Pelvic pain
Oral progesterone blocker

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 20, 2014