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NCT00735553 · ClinicalTrials.gov registry record · Phase 3
Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids
A Phase 3 study, sponsored by Repros Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 77
- Enrollment target
NCT00735553: Clinical Trial Phase 3 study, sponsored by Repros Therapeutics.
NCT00735553 is a Phase 3 study that was terminated before completion, run by Repros Therapeutics. The registered enrollment target is 77 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00735553, a Phase 3 study, was terminated before completion, sponsored by Repros Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 77 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
- DRUG Placebo
- DRUG Proellex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2008-08 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
Why NCT00735553 stopped before completion
NCT00735553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00735553 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00735553 about?
NCT00735553 is a clinical study titled "Evaluating the Safety and Efficacy of Proellex® (CDB-4124) 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 NCT00735553?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2008-08. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00735553?
The interventions under investigation include: Placebo (DRUG), Proellex (DRUG).
Who is sponsoring clinical trial NCT00735553?
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 NCT00735553's enrollment target sits among peer trials
77 1771st of 2000 higher than 228 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
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