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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01451424
The ClinicalTrials.gov registry entry for NCT01451424 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 240-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (83% lower). The listed sponsor is Repros Therapeutics, which has 50 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
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