Study Stopped
Repros stopped study due to safety and FDA placed study on hold
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids
A Phase III Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® in the Treatment of Women Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304
1 other identifier
interventional
27
1 country
4
Brief Summary
Safety and efficacy study of 25 and 50 mg doses of Proellex
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2009
Shorter than P25 for phase_3
4 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
April 1, 2009
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
February 10, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedResults Posted
Study results publicly available
August 21, 2014
CompletedAugust 21, 2014
August 1, 2014
4 months
February 10, 2010
June 25, 2014
August 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)
During two 4 month treatment periods
Study Arms (2)
50 mg Proellex®
ACTIVE COMPARATOR2, 25 mg capsules
25 mg Proellex®
ACTIVE COMPARATOR1, 25 mg capsule
Interventions
Eligibility Criteria
You may qualify if:
- At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
- Subject has a menstrual cycle lasting from 20 to 40 days.
- Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304
You may not qualify if:
- Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
- Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Visions Clinical Research
Boynton Beach, Florida, 33472, United States
Insignia Clinical Research (Tampa Bay Women's Center)
Tampa, Florida, 33067, United States
Advances in Health Inc
Houston, Texas, 77030, United States
The Women's Hospital of Texas, Clinical Research Center
Houston, Texas, 77054, 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 vanAS, PhD, Md
Repros Therapeutics Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2010
First Posted
February 17, 2010
Study Start
April 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 21, 2014
Results First Posted
August 21, 2014
Record last verified: 2014-08