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

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ClinicalTrials.gov Identifier: NCT00958412
Recruitment Status : Terminated (Repros stopped the study for safety and FDA put the study on hold for safety.)
First Posted : August 13, 2009
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

August 11, 2009
August 13, 2009
June 24, 2014
February 2009
August 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00958412 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study
A Randomized, Double-blind Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Premenopausal Women With Symptomatic Endometriosis-extension Study
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Endometriosis
Drug: Proellex®
one (1) 25 mg capsule daily
Other Name: CDB-4124
Experimental: Proellex®
25 mg Proellex®
Intervention: Drug: Proellex®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
Same as current
August 2009
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 48 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00958412
ZPE-201 EXT
Yes
Not Provided
Not Provided
Repros Therapeutics Inc.
Repros Therapeutics Inc.
Not Provided
Study Director: Andre van As, MD, PhD Repros Therapeutics Inc.
Repros Therapeutics Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP