HealthyPhase 1NCT00041899
Comparison of Blood Levels of Two Formulations of the Selective Hormone Receptor Modulator CDB-2914
A Phase 1 study testing CDB-2914 and COB-2914 in people with Healthy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CDB-2914 and COB-2914
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Mar 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- General inclusion criteria:
- Female gender--to evaluate effects in the target population for clinical trials.
- In good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at discretion of the principal investigator. Interval use of over-the-counter drugs is acceptable but must be recorded.
- Hemoglobin greater than 10 g/dL.
- Willing and able to comply with study requirements.
- Age 18 to 50.
Show all 9Show fewer
- Additional inclusion criteria for pre-menopausal women:
- Using mechanical (condoms, diaphragms), abstinence, oral contraceptive, IUD or sterilization methods of contraception for the duration of the study. Because the effect of CDB-2914 on IUD efficacy is not known, women using this form of birth control will be advised to use barrier methods during the cycle(s) in which they participate.
- Negative urine pregnancy test within one week of the first study. If the second study occurs in a subsequent cycle, the pregnancy test will be repeated.
Who cannot join
- Significant abnormalities in the history, physical or laboratory examination
- Pregnancy
- Lactation
- Use of oral, injectable or inhaled glucocorticoids or megesterol within the last year
- Unexplained vaginal bleeding
- History of malignancy within the past 5 years
- Use of anti-epileptic agents
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, 20892
About this study
Official title: Pharmacokinetic Comparison of Two Preparations of the Selective Progesterone Receptor Modular CDB2914
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.
Read more
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- CDB-2914, COB-2914
- Keywords
- Progesterone, Cortisol, Menstrual Cycle, Formulation, Endometrium, Estrogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDB-2914Drug
COB-2914Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2002 (estimated)
- Study startMay 2002
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041899
- Sponsor's protocol ID
- 020219
- Other IDs
- 02-CH-0219
- Status last verified
- Mar 2005
- First submitted
- 18 Jul 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Batista MC, Cartledge TP, Zellmer AW, Merino MJ, Axiotis C, Loriaux DL, Nieman LK. Delayed endometrial maturation induced by daily administration of the antiprogestin RU 486: a potential new contraceptive strategy. Am J Obstet Gynecol. 1992 Jul;167(1):60-5. doi: 10.1016/s0002-9378(11)91627-5.
PubMed 1442957Cadepond F, Ulmann A, Baulieu EE. RU486 (mifepristone): mechanisms of action and clinical uses. Annu Rev Med. 1997;48:129-56. doi: 10.1146/annurev.med.48.1.129.
PubMed 9046951D'Argenio DZ, Schumitzky A. A program package for simulation and parameter estimation in pharmacokinetic systems. Comput Programs Biomed. 1979 Mar;9(2):115-34. doi: 10.1016/0010-468x(79)90025-4.
PubMed 761456
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Comparison of Two Preparations of the Selective Progesterone Receptor Modular CDB2914
- ClinicalTrials.gov ID
- NCT00041899
- Acronym / sponsor ID
- 020219
- Conditions
- Healthy
- Keywords
- Progesterone, Cortisol, Menstrual Cycle, Formulation, Endometrium, Estrogen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- May 2002
- Study completion
- Mar 2005
- First posted
- 19 Jul 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Female gender--to evaluate effects in the target population for clinical trials.
- In good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at discretion of the principal investigator. Interval use of over-the-counter drugs is acceptable but must be recorded.
- Hemoglobin greater than 10 g/dL.
- Willing and able to comply with study requirements.
- Age 18 to 50.
Key exclusion criteria (7 listed)
- Significant abnormalities in the history, physical or laboratory examination
- Pregnancy
- Lactation
- Use of oral, injectable or inhaled glucocorticoids or megesterol within the last year
- Unexplained vaginal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDB-2914 | Drug | – |
| COB-2914 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 1442957Batista MC, Cartledge TP, Zellmer AW, Merino MJ, Axiotis C, Loriaux DL, Nieman LK. Delayed endometrial maturation induced by daily administration of the antiprogestin RU 486: a potential new contraceptive strategy. Am J Obstet Gynecol. 1992 Jul;167(1):60-5. doi: 10.1016/s0002-9378(11)91627-5.
- Background: PubMed 9046951Cadepond F, Ulmann A, Baulieu EE. RU486 (mifepristone): mechanisms of action and clinical uses. Annu Rev Med. 1997;48:129-56. doi: 10.1146/annurev.med.48.1.129.
- Background: PubMed 761456D'Argenio DZ, Schumitzky A. A program package for simulation and parameter estimation in pharmacokinetic systems. Comput Programs Biomed. 1979 Mar;9(2):115-34. doi: 10.1016/0010-468x(79)90025-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDB-2914 and COB-2914 in people with Healthy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00041899, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.