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NCT00958334 · ClinicalTrials.gov registry record · Phase 2
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
A Phase 2 study of Uterine Fibroids, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 11
- Study locations
NCT00958334: Completed Phase 2 study of Uterine Fibroids, sponsored by Repros Therapeutics.
NCT00958334 is a Phase 2 study of Uterine Fibroids that has completed, run by Repros Therapeutics. The registered enrollment target is 65 participants, below the 238-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (73% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00958334, a Phase 2 study of Uterine Fibroids, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 11
- Study locations
Study Summary
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.
Primary Outcome
An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data.
Conditions Studied
Interventions
- DRUG Proellex®
Study Locations (11)
Arizona
- Women's Health Research - Phoenix
- Arizona Wellness Centre for Women - Phoenix
California
- Medical Centre for Clinical Research - San Diego
- Women's Health Care, Inc. - San Diego
Texas
- Advances in Health Inc. - Houston
- Obstetrical & Gynecolgical Associates, PA (OGA) - Houston
Colorado
- Downtown Women's Health Care - Denver
Florida
- Insignia Clinical Research (Tampa Bay Women's Center) - Tampa
Nevada
- Affiliated Clinical Research, Inc. - Las Vegas
South Carolina
- SC Clinical Research Center - Columbia
Washington
- Women's Clinical Research Centre - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2006-09-07 |
| Est. Completion | 2008-10-15 |
| Phase | Phase 2 |
What the finished NCT00958334 record still lists
NCT00958334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 238-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Uterine Fibroids appearing as the primary indexed condition, and to 1 intervention - of which Proellex® is the first listed.
NCT00958334 lists 11 locations in 8 states (Arizona, California, Texas).
Frequently Asked Questions
What is clinical trial NCT00958334 about?
NCT00958334 is a clinical study titled "Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003". ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.
What is the current status of trial NCT00958334?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2006-09-07. Estimated completion is 2008-10-15.
What conditions does trial NCT00958334 study?
This clinical trial studies the following conditions: Uterine Fibroids.
What interventions are being tested in trial NCT00958334?
The interventions under investigation include: Proellex® (DRUG).
Who is sponsoring clinical trial NCT00958334?
This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00958334 being conducted?
This trial has 11 study locations across Arizona, California, Colorado, Florida, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00958334's enrollment target sits among peer trials
65 5th of 10 higher than 6 of 10 other Uterine Fibroids trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Uterine Fibroids trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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