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Protocol Number:
96-CH-0033
- Title:
An Open, Randomized, Long-Term Clinical Trial of Flutamide, Testolactone, and Reduced Hydrocortisone Dose vs. Conventional Treatment of Children with Congenital Adrenal Hyperplasia
- Number:
96-CH-0033
- Summary:
This study was developed to determine if a combination of four drugs (flutamide, testolactone, reduced hydrocortisone dose, and fludrocortisone) can normalize growth in children with congenital adrenal hyperplasia.
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.
- Sponsoring Institute:
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National Institute of Child Health and Human Development (NICHD)
- Recruitment Detail
- Type:
No longer recruiting/follow-up only
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
None
- Eligibility Criteria:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Special Instructions:
Currently Not Provided
- Keyword(s):
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21-Hydroxylase Deficiency
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11-Hydroxylase Deficiency
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Antiandrogen
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Aromatase Inhibitor
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Growth Disorder
- Recruitment Keyword(s):
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Congenital Adrenal Hyperplasia (CAH)
- Condition(s):
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Congenital Adrenal Hyperplasia
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Growth Disorder
- Investigational Drug(s):
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Flutamide and Testolactone
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Deslorelin
- Investigational Device(s):
- None
- Interventions:
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Drug: Flutamide and Testolactone
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Drug: Deslorelin
- Supporting Site:
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National Institute of Child Health and Human Development
- Contact(s):
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This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Citation(s):
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Congenital adrenal hyperplasia due to 21-hydroxylase deficiency
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A preliminary study of flutamide, testolactone, and reduced hydrocortisone dose in the treatment of congenital adrenal hyperplasia
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New approaches to the treatment of congenital adrenal hyperplasia
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009
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