Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041899
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-07-18
Brief Title:
Comparison of Blood Levels of Two Formulations of the Selective Hormone Receptor Modulator CDB-2914
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pharmacokinetic Comparison of Two Preparations of the Selective Progesterone Receptor Modular CDB2914
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 700 am 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
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 700 am 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
Detailed Description:
In recent years compounds that are structurally similar to the naturally occurring steroids have been examined for their ability to block or substitute for the action of the naturally occurring steroids On occasion these substances have both effects depending on the tissue that is examined or on the physiology of the person receiving the agent The development of these kinds of compounds called selective hormone receptor modulators may provide new treatments that are targeted to specific organs or tissues One example of these compounds is the selective estrogen receptor modulator raloxifene which blocks estrogen action at the uterus and acts like estrogen at the bone allowing its use in post-menopausal women as estrogen replacement therapy without requiring progesterone
This study evaluates the progesterone receptor modulator CDB-2914 Earlier studies using single doses of this compound show that it can slow ovarian and uterine development during the menstrual cycle and can induce menses depending on when it is given during the menstrual cycle
Many steroids have an improved bioavailability when given in a micronized formulation Previous studies with CDB-2914 have used crystalline powder up to a dose of 200 mg We wish to compare the pharmacokinetic profile of crystalline and micronized CDB-2914 10 mg The drug will be given as a single oral dose and blood will be drawn frequently over 12 hours and then daily for five days for measurement of the compound
This study evaluates the progesterone receptor modulator CDB-2914 Earlier studies using single doses of this compound show that it can slow ovarian and uterine development during the menstrual cycle and can induce menses depending on when it is given during the menstrual cycle
Many steroids have an improved bioavailability when given in a micronized formulation Previous studies with CDB-2914 have used crystalline powder up to a dose of 200 mg We wish to compare the pharmacokinetic profile of crystalline and micronized CDB-2914 10 mg The drug will be given as a single oral dose and blood will be drawn frequently over 12 hours and then daily for five days for measurement of the compound
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-CH-0219 | None | None | None |