Study Stopped
Repros stopped the study for safety and FDA put the study on hold for safety.
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext
An Open-Label Extension Study Evaluating Safety and Efficacy of Proellex® In Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext
1 other identifier
interventional
4
1 country
1
Brief Summary
An open label, extension study for subjects completing the ZPU-003 Ext 1 study.
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 Jun 2008
Shorter than P25 for phase_2
1 active site
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
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 11, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2009
CompletedResults Posted
Study results publicly available
August 25, 2014
CompletedAugust 25, 2014
August 1, 2014
1.2 years
August 11, 2009
June 25, 2014
August 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
three 4 month cycles separated by off-drug intervals
Study Arms (1)
25 mg Proellex
EXPERIMENTAL25 mg Proellex daily
Interventions
Eligibility Criteria
You may qualify if:
- Four subjects at one site whom have completed ZPU 003 Ext 1 study
You may not qualify if:
- All other subjects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Advances in Health, Inc.
Houston, Texas, 77030, 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
- Jennifer Wike
- Organization
- Repros Therapeutics Inc.
Study Officials
- STUDY DIRECTOR
Andre van As, MD, PhD
Repros Therapeutics Inc.
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
June 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 25, 2014
Results First Posted
August 25, 2014
Record last verified: 2014-08