Comparison of Blood Levels of Two Formulations of the Selective Hormone Receptor Modulator CDB-2914
Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
Participant gender:
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 either crystalline or micronized powder form)
and then at the following times after taking the drug: 15, 30, 45, 60, 75, 90, 105, 120, 150
and 180 minutes (3 hours), and 4, 6, 8, 10, 12, 24, 48, 72, 96, 120 hours (5 days).
Participants will take all their meals in the day hospital or ward during the first 26 hours
of sampling. Inpatients will leave the hospital after the 24-hour blood draw and return as an
outpatient on days 2 through 5. At the 48-hour time point, additional blood will be drawn to
check blood counts and chemistries, and for liver and kidney function tests.
Phase:
Phase 1
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)