Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia

• Register: ClinicalTrials.gov
• Last refreshed on: 20 May 2024
• Main ID: NCT00001521
• Date of registration: 03/11/1999
• Prospective Registration: No
• Primary sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Public title: Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia
• Scientific title: An Open, Randomized, Long-Term Clinical Trial of Flutamide, Testolactone, and Reduced Hydrocortisone Dose vs. Conventional Treatment of Children With Congenital Adrenal Hyperplasia
• Date of first enrolment: June 8, 1995
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT00001521
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Deborah P Merke, M.D.
• Affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Key inclusion & exclusion criteria

- 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).



Age minimum: 2 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Congenital Adrenal Hyperplasia (CAH)

Intervention(s)

Drug: Fludrocortisone

Drug: Hydrocortisone

Drug: Flutamide

Drug: Letrozole

Primary Outcome(s)

Adult height [Time Frame: at 13 for boys; 14 for girls]

Secondary Outcome(s)

Weight velocity (SD units) [Time Frame: at study conclusion and analysis]

Growth velocity (SD units) [Time Frame: at study conclusion and analysis]

Predicted adult height (Bayley-Pinneau) [Time Frame: at study conclusion and analysis]

hormone levels (plasma, urine) [Time Frame: at study conclusion and analysis]

Secondary ID(s)

96-CH-0033

960033

Source(s) of Monetary Support

Please refer to primary and secondary sponsors