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NCT00853567 · ClinicalTrials.gov registry record · Phase 3
Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids
A Phase 3 study, sponsored by Repros Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 71
- Enrollment target
NCT00853567 is a Phase 3 study that was terminated before completion, run by Repros Therapeutics. The registered enrollment target is 71 participants.
The verdict
NCT00853567, a Phase 3 study, was terminated before completion, sponsored by Repros Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 71 participants
- Enrollment target
Study Summary
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.
Interventions
- OTHER placebo
- DRUG Proellex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2009-02 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00853567
The ClinicalTrials.gov registry entry for NCT00853567 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Repros Therapeutics, which has 50 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00853567 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00853567 about?
NCT00853567 is a clinical study titled "Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids". Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.
What is the current status of trial NCT00853567?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 71 participants. The study started on 2009-02. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00853567?
The interventions under investigation include: placebo (OTHER), Proellex (DRUG).
Who is sponsoring clinical trial NCT00853567?
This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.
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