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An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext

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ClinicalTrials.gov Identifier: NCT00958893
Recruitment Status : Terminated (Repros stopped the study for safety and FDA put the study on hold for safety.)
First Posted : August 13, 2009
Results First Posted : August 25, 2014
Last Update Posted : August 25, 2014
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Brief Summary:
An open label, extension study for subjects completing the ZPU-003 Ext 1 study.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Drug: 25 mg Proellex Phase 2

Detailed Description:
This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cycles separated by off drug intervals.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study Evaluating Safety and Efficacy of Proellex® In Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext
Study Start Date : June 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Arm Intervention/treatment
Experimental: 25 mg Proellex
25 mg Proellex daily
Drug: 25 mg Proellex
one 25 mg capsules
Other Names:
  • CDB-4124
  • Proellex



Primary Outcome Measures :
  1. To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals. [ Time Frame: three 4 month cycles separated by off-drug intervals ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Four subjects at one site whom have completed ZPU 003 Ext 1 study

Exclusion Criteria:

  • All other subjects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958893


Locations
United States, Texas
Advances in Health, Inc.
Houston,, Texas, United States, 77030
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Andre van As, MD, PhD Repros Therapeutics Inc.

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00958893     History of Changes
Other Study ID Numbers: ZPU-003 Extension 2
First Posted: August 13, 2009    Key Record Dates
Results First Posted: August 25, 2014
Last Update Posted: August 25, 2014
Last Verified: August 2014

Keywords provided by Repros Therapeutics Inc.:
Uterine fibroids

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases