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Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
NCT00958334 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00958334
The ClinicalTrials.gov registry entry for NCT00958334 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Repros Therapeutics, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00958334 reports 11 study locations spanning 8 distinct geographic areas — top geographies include Arizona, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00958334?
The interventions under investigation include: Proellex® (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00958334?
This trial is sponsored by Repros Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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