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Protocol 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
Gender: Male & Female
Min Age: 2 Years
Max Age: 18 Years

Referral Letter Required

Yes

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Congenital Adrenal Hyperplasia (CAH);
Intervention;
Children

Recruitment Keyword(s)

Congenital Adrenal Hyperplasia (CAH)

Condition(s)

Congenital Adrenal Hyperplasia (CAH)

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Drug: Flutamide
Drug: Letrozole
Drug: Hydrocortisone
Drug: Fludrocortisone

Supporting Site

National Institute of Child Health and Human Development

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. <TAB>

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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).


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Citations:

Urban MD, Lee PA, Migeon CJ. Adult height and fertility in men with congenital virilizing adrenal hyperplasia. N Engl J Med. 1978 Dec 21;299(25):1392-6.

New MI, Gertner JM, Speiser PW, del Balzo P. Growth and final height in classical and nonclassical 21-hydroxylase deficiency. Acta Paediatr Jpn. 1988;30 Suppl:79-88.

Klingensmith GJ, Garcia SC, Jones HW, Migeon CJ, Blizzard RM. Glucocorticoid treatment of girls with congenital adrenal hyperplasia: effects on height, sexual maturation, and fertility. J Pediatr. 1977 Jun;90(6):996-1004.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Deborah P. Merke, M.D.
National Institutes of Health Clinical Center (CC)
BG 10-CRC RM 3-2740
10 CENTER DR
BETHESDA MD 20814
(301) 496-0718
dmerke@nih.gov

Deborah P. Merke, M.D.
National Institutes of Health Clinical Center (CC)
BG 10-CRC RM 3-2740
10 CENTER DR
BETHESDA MD 20814
(301) 496-0718
dmerke@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00001521

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