Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia
Congenital Adrenal Hyperplasia, 21-Hydroxylase Deficiency, Adrenogenital Syndrome
About this trial
This is an interventional treatment trial for Congenital Adrenal Hyperplasia focused on measuring Congenital Adrenal Hyperplasia, Hydrocortisone, Pharmacokinetic, Pharmacodynamic
Eligibility Criteria
- INCLUSION CRITERIA:
Satisfactory pre-trial screening
Provision of signed written informed consent and written assent from patients less than 18 years old, as applicable.
Good general health.
Females of childbearing potential must have a negative pregnancy test initially and at all visits. Females who are engaging in sexual intercourse must be using medically acceptable method of contraception.
EXCLUSION CRITERIA:
Co-morbid condition requiring daily administration of a medication that induces hepatic enzymes or interferes with the metabolism of glucocorticoids.
Clinical or biochemical evidence of hepatic or renal disease. Creatinine above the normal range or elevated liver function tests (Transaminases greater than 1.5 the upper limits of normal).
Females who are pregnant or lactating.
Patients with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the trial.
Participation in another clinical trial of an investigational or licensed drug or device within 3 months prior to inclusion in this study.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
Cortef and Chronocort
Cortef 3 times daily(total dose 30 mg)for minimum of 7 days followed by Chronocort 30 mg once daily nigh time dose for 28 +/- 3 days duration