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NCT00290251 · ClinicalTrials.gov registry record · Phase 2
Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914
A Phase 2 study of Leiomyoma, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 2
- Study locations
NCT00290251: Completed Phase 2 study of Leiomyoma, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00290251 is a Phase 2 study of Leiomyoma that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 72 participants, below the 97-participant average among 8 other Leiomyoma trials with a reported enrollment target (26% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00290251, a Phase 2 study of Leiomyoma, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.
Primary Outcome
The primary outcome, fibroid volume, was calculated by an ellipsoid formula (π/6xd1xd2xd3) using orthogonal three-dimensional measurements taken from pelvic MRI scan. Individual volumes were summed to assess total fibroid volume for each woman, which were log-transformed before analysis. Women with paired MRI results were included in this intent to treat analysis, even if they did not take all study medication. Fibroids were included if they were seen on both studies.The absolute change in cm3 b
Conditions Studied
Interventions
- DRUG placebo
- DRUG ulipristal acetate 20 mg
- DRUG ulipristal acetate 10 mg
Study Locations (2)
Maryland
- NIH Clinical Center - Bethesda
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2006-02 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT00290251 record still lists
NCT00290251 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 97-participant average among 8 other Leiomyoma trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Leiomyoma appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT00290251 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00290251 about?
NCT00290251 is a clinical study titled "Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914". This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.
What is the current status of trial NCT00290251?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2006-02. Estimated completion is 2010-08.
What conditions does trial NCT00290251 study?
This clinical trial studies the following conditions: Leiomyoma.
What interventions are being tested in trial NCT00290251?
The interventions under investigation include: placebo (DRUG), ulipristal acetate 20 mg (DRUG), ulipristal acetate 10 mg (DRUG).
Who is sponsoring clinical trial NCT00290251?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00290251 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Leiomyoma
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 NCT00290251's enrollment target sits among peer trials
72 5th of 8 higher than 4 of 8 other Leiomyoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leiomyoma 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
-
Effects of Simvastatin on Uterine Leiomyoma Size
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Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist
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