Three Cycle Extension Study Evaluating Safety and Efficacy of a 25 mg Daily Dose of Proellex® In Pre-Menopausal Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext

This study has been terminated.
(Repros decided to stop the study because of safety and the FDA decided to put the study on hold because of safety.)
Sponsor:
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00958893
First received: August 11, 2009
Last updated: February 10, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Uterine Fibroids
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: Center, Open-Label, Three Cycle Extension Study Evaluating Safety and Efficacy of a 25 mg Daily Dose of Proellex® (CDB-4124) In Pre-Menopausal Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate differences in fibroid size reduction from baseline of the 25 mg dose and with specific attention to the duration of this size reduction during off drug intervals. [ Time Frame: Three 4 month cycles separated by off-drug intervals ] [ Designated as safety issue: No ]

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: Proellex® Drug: Proellex®
one 25 mg capsules
Other Name: CDB-4124

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958893

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

No publications provided

Responsible Party: Andre vanAs, MD, PhD, Repros Therapeutics
ClinicalTrials.gov Identifier: NCT00958893     History of Changes
Other Study ID Numbers: ZPU-003 Extension 2
Study First Received: August 11, 2009
Last Updated: February 10, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014