Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia
Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
Participant gender:
Summary
This study will test a new, extended release form of hydrocortisone called Chronocort in
patients with congenital adrenal hyperplasia (CAH). People with CAH do not make enough of the
adrenal hormones cortisol and aldosterone, and their adrenal glands make too much of the sex
hormone androgen. Medicines called glucocorticoids (hydrocortisone, dexamethasone and
prednisone) are currently used to treat CAH, but finding the best dose of these drugs that
effectively lowers androgens without causing undesirable side effects, such as weight gain
and slow growth rate in children, is often difficult to achieve.
Adolescents and adults with CAH due to 21-hydroxylase deficiency may be eligible for this
study. Children 16 years of age and older are eligible with confirmation by bone age that
they are no longer growing.
Participants undergo the following tests and procedures during two inpatient visits one month
apart at the NIH Clinical Center:
- Medical history and physical examination.
- Medications: Following 7 days of Cortef (standard drug treatment for CAH), patients
begin taking Chronocort on day 3 of hospitalization and continue the tablets once a day
for 1 month.
- Blood tests: A catheter (plastic tube) is inserted in a vein and left in place for
frequent blood draws in order to avoid repeated needlesticks. Blood is drawn for
chemistries, blood count, pregnancy test in women, and for serial tests (up to 26
samples in a 24-hour period) to measure hormone levels.
- 24-hour urine test.
- Height and weight measurements.
Between the two hospitalizations, patients are contacted by NIH weekly to check for possible
side effects from Chronocort. Two weeks after the first visit, patients also will have blood
drawn by their regular doctor or a local clinic. A few days before the second
hospitalization, patients undergo a 20-minute telephone questionnaire about energy level and
well being.
About 30 days after discharge from the second hospitalization, patients are followed up with
a telephone call to see how they are doing.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Diurnal Limited
Collaborator:
National Institutes of Health Clinical Center (CC)