Back to resultsAn Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext
Primary Purpose
Uterine Fibroids
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
25 mg Proellex
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids focused on measuring Uterine fibroids
Eligibility Criteria
Inclusion Criteria:
- Four subjects at one site whom have completed ZPU 003 Ext 1 study
Exclusion Criteria:
- All other subjects
Sites / Locations
- Advances in Health, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
25 mg Proellex
Arm Description
25 mg Proellex daily
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00958893
First Posted
August 11, 2009
Last Updated
August 8, 2014
Sponsor
Repros Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00958893
Brief Title
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext
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 Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Repros stopped the study for safety and FDA put the study on hold for safety.
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Repros Therapeutics Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An open label, extension study for subjects completing the ZPU-003 Ext 1 study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
Uterine fibroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
25 mg Proellex
Arm Type
Experimental
Arm Description
25 mg Proellex daily
Intervention Type
Drug
Intervention Name(s)
25 mg Proellex
Other Intervention Name(s)
CDB-4124, Proellex
Intervention Description
one 25 mg capsules
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Four subjects at one site whom have completed ZPU 003 Ext 1 study
Exclusion Criteria:
All other subjects
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre van As, MD, PhD
Organizational Affiliation
Repros Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Advances in Health, Inc.
City
Houston,
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext
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