At a glance
ClinicalIndex Comparison Record- ✓Boys with bone age 2 to 13 years OR girls with bone age 2 to 11 years
- ✓CAH due to classic 21-hydroxylase deficiency
- ✓Either prepubertal OR on GnRH agonist therapy for secondary central precocious puberty
- ✕Concurrent illnesses requiring glucocorticoid treatment (e.g. severe asthma)
- ✕Requiring drugs that markedly alter hydrocortisone metabolism (e.g. anticonvulsants)
- ✕Cannot be brought into reasonable control with conventional treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open, Randomized, Long-Term Clinical Trial of Flutamide, Testolactone, and Reduced Hydrocortisone Dose vs. Conventional Treatment of Children With Congenital Adrenal Hyperplasia
In Brief
A Phase 3 clinical trial evaluating Fludrocortisone, Hydrocortisone, and 3 other interventions for Congenital Adrenal Hyperplasia (CAH). Completed, enrolled 66 participants across 1 site.
Detailed 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 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.
Study Details
Timeline
Interventions
Mineralocorticoid needed to replace aldosterone deficiency. Patients will continue to receive an optimal fludrocortisone dose
Glucocorticoid needed to replace cortisol deficiency. Reduced hydrocortisone dose might normalize the growth and adult stature of children with congenital adrenal hyperplasia
Aromatase inhibitors work by inhibiting the action of the enzyme aromatase, which converts androgens into estrogens by a process called aromatization.
Non steroidal anti-androgen that prevents the action of androgens by blocking receptor sites in target tissue. It may also produce changes in testosterone and estradiol
Aromatase inhibitors work by inhibiting the action of the enzyme aromatase, which converts androgens into estrogens by a process called aromatization.