Explore the NIHProtocol Details
An Open, Randomized, Long-Term Clinical Trial of Flutamide, Testolactone, and Reduced Hydrocortisone Dose vs. Conventional Treatment of Children with Congenital Adrenal Hyperplasia
This study is NOT currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
96-CH-0033 |
Sponsoring Institute |
National Institute of Child Health and Human Development (NICHD) |
Recruitment Detail |
Type: No longer recruiting/follow-up only |
Referral Letter Required |
No |
Population Exclusion(s) |
None |
Special Instructions |
Currently Not Provided |
Keywords |
21-Hydroxylase Deficiency; |
Recruitment Keyword(s) |
Congenital Adrenal Hyperplasia (CAH) |
Condition(s) |
Congenital Adrenal Hyperplasia; |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Drug: Flutamide and Testolactone |
Supporting Site |
|
The study will take 60 children, boys and girls and divide them into 2 groups based on the medications given. Group one will receive the new four- drug combination. Group two will receive the standard treatment for congenital adrenal hyperplasia (hydrocortisone and fludrocortisone).
The boys in group one will take the medication until the age of 14 at which time they will stop taking the four drug combination and begin receiving the standard treatment for congenital adrenal hyperplasia. Girls in group one will take the four drug combination until the age of 13, at which time they will stop and begin receiving the standard treatment for congenital adrenal hyperplasia plus flutamide. Flutamide will be given to the girls until six months after their first menstrual period.
All of the children will be followed until they reach their final adult height. The effectiveness of the treatment will be determined by measuring the patient's adult height, body mass index, and bone density.
Eligibility
INCLUSION CRITERIA:
Subjects will be boys with bone ages 2 to 13 years and girls with bone ages 2 to 11 years with classic 21-hydroxylase.
Subjects must either not yet have undergone pubertal activation of the hypothalamic-pituitary-gonadal axis, or, if pubertal activation has occurred, must be receiving an LHRH agonist to suppress secondary central precocious puberty.
Children with a bone age of 1 to 2 years may enroll in the protocol for optimization of conventional therapy, but will not be randomized to a study arm until the bone age reaches 2.
EXCLUSION CRITERIA:
Children who have concurrent illnesses requiring glucocorticoid treatment (such as severe asthma), or requiring drugs that markedly alter hydrocortisone metabolism (such as anticonvulsants), and children who cannot be brought into reasonable control with conventional treatment (an unusual occurrence).
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Deborah P. Merke, M.D. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 1-2740 10 Center Drive Bethesda, Maryland 20892 (301) 496-0718 dmerke@mail.cc.nih.gov |
Deborah P. Merke, M.D. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 1-2740 10 Center Drive Bethesda, Maryland 20892 (301) 496-0718 dmerke@mail.cc.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00001521
QUESTIONS?
Contact the Patient Recruitment and Public Liaison Office for:
- Details on how to participate in a study
- Details on how to refer a patient to a study
NIH Clinical Studies Information Request
Contact the Office of Communications for:
- General information about the NIH Clinical Center
Contact the Department Clinical Research Informatics, (DCRI) for:
- Technical questions about Adobe Acrobat and the PDF format
- Technical questions about this web server
