Back to resultsStudy Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study
Primary Purpose
Endometriosis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Proellex®
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Pelvic pain, Oral progesterone blocker
Eligibility Criteria
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
Sites / Locations
- Advanced Clinical Therapeutics, LLC
- Medical Center for Clinical Research
- Compass Clinical Research
- Comprehensive Clinical Trials
- Physicians for Women
- HWC Women's Research Center
- Clinical Trials of Texas/Institute for Women's Health
- Clinical Trials of Texas/Seven Oaks Women's Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Proellex®
Arm Description
25 mg Proellex®
Outcomes
Primary Outcome Measures
To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily
Number of participants who experienced 1 or more adverse event.
Secondary Outcome Measures
Full Information
NCT ID
NCT00958412
First Posted
August 11, 2009
Last Updated
January 23, 2019
Sponsor
Repros Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00958412
Brief Title
Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study
Official Title
A Randomized, Double-blind Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Premenopausal Women With Symptomatic Endometriosis-extension Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Repros stopped the study for safety and FDA put the study on hold for safety.
Study Start Date
February 28, 2009 (Actual)
Primary Completion Date
August 31, 2009 (Actual)
Study Completion Date
August 31, 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
ZPE-201 Extension of treatment
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Pelvic pain, Oral progesterone blocker
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proellex®
Arm Type
Experimental
Arm Description
25 mg Proellex®
Intervention Type
Drug
Intervention Name(s)
Proellex®
Other Intervention Name(s)
CDB-4124
Intervention Description
one (1) 25 mg capsule daily
Primary Outcome Measure Information:
Title
To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily
Description
Number of participants who experienced 1 or more adverse event.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Chan
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Clinical Therapeutics, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Compass Clinical Research
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Comprehensive Clinical Trials
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Physicians for Women
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
HWC Women's Research Center
City
Miamisburg
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Clinical Trials of Texas/Institute for Women's Health
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Trials of Texas/Seven Oaks Women's Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study
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