Study Stopped
Repros stopped the study for safety and FDA put the study on hold for safety.
Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study
A Randomized, Double-blind Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Premenopausal Women With Symptomatic Endometriosis-extension Study
1 other identifier
interventional
18
1 country
8
Brief Summary
ZPE-201 Extension of treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2009
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2009
CompletedFirst Submitted
Initial submission to the registry
August 11, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2009
CompletedResults Posted
Study results publicly available
February 12, 2019
CompletedFebruary 12, 2019
January 1, 2019
6 months
August 11, 2009
June 25, 2014
January 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily
Number of participants who experienced 1 or more adverse event.
6 months
Study Arms (1)
Proellex®
EXPERIMENTAL25 mg Proellex®
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- All other subjects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, 85712, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Compass Clinical Research
San Ramon, California, 94583, United States
Comprehensive Clinical Trials
West Palm Beach, Florida, 33409, United States
Physicians for Women
Cary, North Carolina, 27518, United States
HWC Women's Research Center
Miamisburg, Ohio, 45322, United States
Clinical Trials of Texas/Institute for Women's Health
San Antonio, Texas, 78229, United States
Clinical Trials of Texas/Seven Oaks Women's Center
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Anna Chan
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2009
First Posted
August 13, 2009
Study Start
February 28, 2009
Primary Completion
August 31, 2009
Study Completion
August 31, 2009
Last Updated
February 12, 2019
Results First Posted
February 12, 2019
Record last verified: 2019-01