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NCT00044876 · ClinicalTrials.gov registry record · Phase 2
Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist
A Phase 2 study of Leiomyoma, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT00044876: Completed Phase 2 study of Leiomyoma, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00044876 is a Phase 2 study of Leiomyoma that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 56 participants, below the 99-participant average among 8 other Leiomyoma trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00044876, a Phase 2 study of Leiomyoma, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in premenopausal women. These tumors may cause bleeding, pelvic pain and pressure. Because fibroids grow in the presence of estrogen, medical therapies that decrease estrogen levels (like GnRH analog) cause fibroids to shrink and so may relieve symptoms. However, such medication can only be given short-term and has inconvenient side effects such as hot-flushes. Thus, many women with symptomatic fibroids choose to have them removed surgically, either individually or by removing the uterus via hysterectomy. The study evaluates a new medical treatment for fibroids using the progesterone receptor modulator CDB-2914. A similar compound, mifepristone (Registered Trademark), reduced fibroid size when given for twelve weeks. This study will compare fibroid size, hormone levels and symptoms before and during daily administration of CDB-2914 (10 or 25 mg) or placebo for 10 - 14 weeks. To do this, women will undergo MRI and a saline hysterosonogram (ultrasound with fluid) of the uterus before and at the end of the treatment; they will have blood drawn every 7 - 14 days, and will fill out a symptom calendar at home. Hysterectomy will be performed at the end of the treatment to evaluate the effects of the medication on the uterine and fibroid tissues, and to provide treatment for the study participant. Women will be randomly assigned to the treatment groups; during the treatment period neither the participants nor the investigators will know the type of treatment that a woman receives. ...
Conditions Studied
Interventions
- DRUG CDB-2914
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2002-09-02 |
| Est. Completion | 2015-10-01 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00044876 record still lists
NCT00044876 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 99-participant average among 8 other Leiomyoma trials with a reported enrollment target (43% lower).
The record links to 1 condition, with Leiomyoma appearing as the primary indexed condition, and to 1 intervention - of which CDB-2914 is the first listed.
NCT00044876 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00044876 about?
NCT00044876 is a clinical study titled "Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist". Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in premenopausal women. These tumors may cause bleeding, pelvic pain and pressure. Because fibroids grow in the presence of estrogen, medical therapies that decrease estrogen levels (like GnRH analog) cause fibroids to sh...
What is the current status of trial NCT00044876?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2002-09-02. Estimated completion is 2015-10-01.
What conditions does trial NCT00044876 study?
This clinical trial studies the following conditions: Leiomyoma.
What interventions are being tested in trial NCT00044876?
The interventions under investigation include: CDB-2914 (DRUG).
Who is sponsoring clinical trial NCT00044876?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00044876 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT00044876's enrollment target sits among peer trials
56 8th of 8 higher than 1 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
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