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
Number | 96-CH-0033 |
Sponsoring Institute | National Institute of Child Health and Human Development (NICHD) |
Recruitment Detail | Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 2 Years
Max Age: 18 Years |
Referral Letter Required | Yes |
Population Exclusion(s) | None |
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: Fludrocortisone
Drug: Hydrocortisone
Drug: Letrozole
Drug: Flutamide
Drug: Testolactone
|
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 two years after their first menstrual period or until adult height.
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.
Eligibility
INCLUSION CRITERIA:
Subjects will be boys with bone ages 2 to 13 years and girls with bone ages 2 to 11 years with CAH due to classic 21-hydroxylase deficiency.
Subjects must either not yet have undergone pubertal activation of the hypothalamic-pituitary-gonadal axis, or, if pubertal activation has occurred, must be receiving a GnRH 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:
Merke DP, Mallappa A, Parker M, Sukin C, Kulkarni SE, Keil MF, Van Ryzin C, Hill SC, Reynolds JC, Cutler GB Jr, Sinaii N. Adult Height Following Prepubertal Treatment With Antiandrogen, Aromatase Inhibitor, and Reduced Hydrocortisone in CAH. J Clin Endocrinol Metab. 2024 Dec 3:dgae824. doi: 10.1210/clinem/dgae824. Epub ahead of print. PMID: 39672600.
Contacts:
Clinical Trials Number:
NCT00001521Protocol 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
Number | 96-CH-0033 |
Sponsoring Institute | National Institute of Child Health and Human Development (NICHD) |
Recruitment Detail | Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 2 Years
Max Age: 18 Years |
Referral Letter Required | Yes |
Population Exclusion(s) | None |
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: Fludrocortisone
Drug: Hydrocortisone
Drug: Letrozole
Drug: Flutamide
Drug: Testolactone
|
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 two years after their first menstrual period or until adult height.
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.
Eligibility
INCLUSION CRITERIA:
Subjects will be boys with bone ages 2 to 13 years and girls with bone ages 2 to 11 years with CAH due to classic 21-hydroxylase deficiency.
Subjects must either not yet have undergone pubertal activation of the hypothalamic-pituitary-gonadal axis, or, if pubertal activation has occurred, must be receiving a GnRH 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:
Merke DP, Mallappa A, Parker M, Sukin C, Kulkarni SE, Keil MF, Van Ryzin C, Hill SC, Reynolds JC, Cutler GB Jr, Sinaii N. Adult Height Following Prepubertal Treatment With Antiandrogen, Aromatase Inhibitor, and Reduced Hydrocortisone in CAH. J Clin Endocrinol Metab. 2024 Dec 3:dgae824. doi: 10.1210/clinem/dgae824. Epub ahead of print. PMID: 39672600.
Contacts:
Clinical Trials Number:
NCT00001521