Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001521
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
1999-11-03
Brief Title:
Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-05-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients adult height body mass index and bone density TAB
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 patients adult height body mass index and bone density TAB
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 96-CH-0033 | None | None | None |