Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Endocrine, Endocrine, Hematology |
| Therapuetic Areas: | Endocrinology, Hematology |
| Healthy: | No |
| Age Range: | 2 - 18 |
| Updated: | 4/6/2019 |
| Start Date: | February 2, 1996 |
| End Date: | December 31, 2020 |
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 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....
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.
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.
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.
- 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).
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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