Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia
Status:
Completed
Trial end date:
2018-07-28
Target enrollment:
Participant gender:
Summary
This study is a parallel arm, randomised, open-label study, including dose titration and
admissions for four overnight stays for 24-hour endocrine profiles. It will compare the
efficacy, safety and tolerability of Chronocort® with standard glucocorticoid replacement
therapy in the treatment of congenital adrenal hyperplasia (CAH) over a treatment period of 6
months. Dose titration decisions in both treatment groups will be made by a central
independent physician, blinded to the treatment arm, using information generated from the
24-hour endocrine profiles. Each treatment arm will be subject to the same titration rules
throughout the study, ensuring that opportunities for optimisation and control of androgens
are the same in both groups.