Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 3 study, sponsored by Repros Therapeutics.
NCT00853567 is a Phase 3 study that was terminated before completion, run by Repros Therapeutics. The registered enrollment target is 71 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00853567 stopped before completion
NCT00853567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00853567 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00853567's enrollment target sits among peer trials
71 1784th of 2000 higher than 216 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05452889 · 71 participants · Early Phase 1
PET Image in PAH Patients
- NCT05766943 · 71 participants · NA
Reduction of Myopotential Interference With Smart Pass in S-ICD Patients
- NCT06229678 · 71 participants · Early Phase 1
Ketones, SGLT2, HFrEF
- NCT06377566 · 71 participants · Phase 2
A Study of BV-AVD in People With Bulky Hodgkin Lymphoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia