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NCT01451424 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids
A Phase 2 study of Uterine Fibroids, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT01451424: Completed Phase 2 study of Uterine Fibroids, sponsored by Repros Therapeutics.
NCT01451424 is a Phase 2 study of Uterine Fibroids that has completed, run by Repros Therapeutics. The registered enrollment target is 40 participants, below the 240-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01451424, a Phase 2 study of Uterine Fibroids, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally.
Primary Outcome
Change from baseline in vaginal bleeding assessed at the end of treatment (12 or 16 weeks) using a Pictorial Blood Loss Assessment Chart (PBAC), which measures volume (mL) of blood loss over a 28-day period Less blood loss represents an improvement.
Conditions Studied
Interventions
- DRUG Proellex
Study Locations (2)
Florida
- Cetero Research - Miami Gardens
Texas
- Advances in Health - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT01451424 record still lists
NCT01451424 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 240-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (83% 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.
NCT01451424 reports a single indexed study location in Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT01451424 about?
NCT01451424 is a clinical study titled "Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids". To determine the safety, pharmacokinetics and efficacy of 4 doses (3, 6, 12, 24 mg) of Proellex in premenopausal women with uterine fibroids confirmed by ultrasound. Drug will be administered vaginally.
What is the current status of trial NCT01451424?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2012-02. Estimated completion is 2013-01.
What conditions does trial NCT01451424 study?
This clinical trial studies the following conditions: Uterine Fibroids.
What interventions are being tested in trial NCT01451424?
The interventions under investigation include: Proellex (DRUG).
Who is sponsoring clinical trial NCT01451424?
This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01451424 being conducted?
This trial has 2 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Uterine Fibroids
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01451424's enrollment target sits among peer trials
40 7th of 10 higher than 4 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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