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| Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001521 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Adrenal Hyperplasia Growth Disorder |
Drug: Flutamide and Testolactone Drug: Deslorelin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | An Open, Randomized, Long-Term Clinical Trial of Flutamide, Testolactone, and Reduced Hydrocortisone Dose vs. Conventional Treatment of Children With Congenital Adrenal Hyperplasia |
| Estimated Enrollment: | 62 |
| Study Start Date: | February 1996 |
To test the hypothesis that the regimen of flutamide (an antiandrogen), testolactone or letrozole (an inhibitor of androgen-to-estrogen conversion), and reduced hydrocortisone dose can normalize the growth and adult stature of children with congenital adrenal hyperplasia, and can avoid the complications of supraphysiologic glucocorticoid dosage, 60 children with this disorder will be randomized to receive either the above regimen or conventional treatment until they have reached age 13 years in a girl or age 14 in a boy. After these ages boys will receive the conventional treatment and girls will receive conventional treatment plus flutamide. In girls, flutamide will be continued until 6 months after menarche. All children will be followed until they have attained final adult height. The principal outcome measures will be adult height, body mass index, and bone density.
Eligibility| Ages Eligible for Study: | 2 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations More Information
| Study ID Numbers: | 960033, 96-CH-0033 |
| Study First Received: | November 3, 1999 |
| Last Updated: | December 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001521 |
| Health Authority: | United States: Federal Government |
|
21-Hydroxylase Deficiency 11-Hydroxylase Deficiency Antiandrogen |
Aromatase Inhibitor Growth Disorder Congenital Adrenal Hyperplasia (CAH) |
|
Hydrocortisone Metabolic Diseases Cortisol succinate Gonadal Disorders Adrenogenital Syndrome Adrenal Gland Diseases Endocrine System Diseases Testolactone Congenital adrenal hyperplasia due to 21 hydroxylase deficiency Flutamide Adrenocortical Hyperfunction Sex Differentiation Disorders |
Deslorelin Metabolism, Inborn Errors Hyperplasia Adrenal hyperplasia Genetic Diseases, Inborn Growth Disorders Adrenal Hyperplasia, Congenital Hydrocortisone acetate Endocrinopathy Epinephrine Metabolic disorder |
|
Androgen Antagonists Pathologic Processes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists |
Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Steroid Metabolism, Inborn Errors Pharmacologic Actions |
