Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia
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|ClinicalTrials.gov Identifier: NCT00001521|
Recruitment Status : Active, not recruiting
First Posted : November 4, 1999
Last Update Posted : October 25, 2019
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>...
|Condition or disease||Intervention/treatment||Phase|
|Congenital Adrenal Hyperplasia (CAH)||Drug: Flutamide Drug: Letrozole Drug: Hydrocortisone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2, 1996|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Investigational 1
Flutamide, Aromatase inhibitor (testolactone /letrozole) and reduced hydrocortisone dose
Experimental: Investigational 2
Flutamide, Aromatase inhibitor (testolactone/letrozole) and reduced hydrocortisone dose
Non steroidal antiandrogen that prevents the action of androgens by blocking receptor sites in target tissue. It may also produce changes in testosterone and estradiol
- Adult height [ Time Frame: at 13 fpr boys; 14 for girls ]Principal outcome variable for long term study will be final adult height, body mass index, and bone mineral density.
- hormone levels (plasma, urine) [ Time Frame: at study conclusion and analysis ]
- Predicted adult height (Bayley-Pinneau) [ Time Frame: at study conclusion and analysis ]
- Weight velocity (SD units) [ Time Frame: at study conclusion and analysis ]
- Growth velocity (SD units) [ Time Frame: at study conclusion and analysis ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001521
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Deborah P Merke, M.D.||National Institutes of Health Clinical Center (CC)|