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NCT00041899 · ClinicalTrials.gov registry record · Phase 1
Comparison of Blood Levels of Two Formulations of the Selective Hormone Receptor Modulator CDB-2914
A Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00041899 is a Phase 1 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 15 participants.
The verdict
NCT00041899, a Phase 1 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study will compare blood levels of the drug CDB-2914 in healthy women receiving the compound in crystalline powder form with the blood levels of women receiving an identical dose of the drug in micronized form. Generally, absorption of compounds made into a crystalline powder is less than that of micronized compounds, in which the substance is processed into many similar-sized particles. CDB-2914 is a manmade hormone similar to the hormones cortisol and progesterone. The National Institute of Child Health and Human Development is evaluating the ability of this drug to treat reproductive conditions. Institute studies have shown that CDB-2914 can increase the time to produce a mature egg in the ovary, and cause an early menstrual period, CDB-2914 might be used to treat fibroids and endometriosis pain. As part of its evaluation for these purposes, this study will determine if absorption of crystalline and micronized powder forms of CDB-2914 result in the same blood levels of the drug. Women between 18 and 50 years of age who are in good health may be eligible for this study. Premenopausal women must not be pregnant (as determined by a urine pregnancy test) or breastfeeding and must practice birth control during the study. Candidates will be screened with a medical history, physical examination, and blood and urine tests. Women who use an IUD for contraception are advised to also use a barrier contraceptive (diaphragm or condom) the week after taking CDB-2914. Participants will be admitted to the NIH Clinical Center inpatient service or the outpatient day hospital twice for pharmacokinetic studies (blood drawing to measure blood levels of CDB-2914 after a single dose of the drug). They will come to the Clinical Center at 7:00 a.m. and have a catheter (thin plastic tube) inserted into an arm vein for drawing blood for the first 24 hours of the study. Eight milliliters (about 2 teaspoons) of blood will be drawn 5 minutes and 1 minute before taking CDB-2914 (in eit
Interventions
- DRUG CDB-2914
- DRUG COB-2914
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2002-05 |
| Est. Completion | 2005-03 |
| Phase | Phase 1 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00041899
The ClinicalTrials.gov registry entry for NCT00041899 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CDB-2914 is the first listed.
NCT00041899 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00041899 about?
NCT00041899 is a clinical study titled "Comparison of Blood Levels of Two Formulations of the Selective Hormone Receptor Modulator CDB-2914". This study will compare blood levels of the drug CDB-2914 in healthy women receiving the compound in crystalline powder form with the blood levels of women receiving an identical dose of the drug in micronized form. Generally, absorption of compounds made into a crystalline powder is less than that ...
What is the current status of trial NCT00041899?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2002-05. Estimated completion is 2005-03.
What interventions are being tested in trial NCT00041899?
The interventions under investigation include: CDB-2914 (DRUG), COB-2914 (DRUG).
Who is sponsoring clinical trial NCT00041899?
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.
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