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

This study has been terminated.
(Repros stopped the study for safety and FDA put the study on hold for safety.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00958893
First Posted: August 13, 2009
Last Update Posted: August 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Repros Therapeutics Inc.
  Purpose
An open label, extension study for subjects completing the ZPU-003 Ext 1 study.

Condition Intervention Phase
Uterine Fibroids Drug: 25 mg Proellex Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 4
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 25 mg Proellex
25 mg Proellex daily
Drug: 25 mg Proellex
one 25 mg capsules
Other Names:
  • CDB-4124
  • Proellex

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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.
  More Information

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00958893     History of Changes
Other Study ID Numbers: ZPU-003 Extension 2
First Submitted: August 11, 2009
First Posted: August 13, 2009
Results First Submitted: June 25, 2014
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