Once-Daily Dual Release Hydrocortisone Compared to Conventional Glucocorticoids for Adults with Congenital Adrenal Hyperplasia

What this Trial Is About

Researchers are evaluating treatments for congenital adrenal hyperplasia, a genetic disorder caused by 21-hydroxylase deficiency that leads to cortisol deficiency and excess androgens. This trial compares the effects of a once-daily dual-release hydrocortisone preparation versus conventional glucocorticoid therapy on various health aspects including metabolic syndrome, hormonal balance, bone health, quality of life, reproductive and psychological functions, and treatment adherence. The study is open and controlled, aiming to improve management strategies for adults with this condition. Participants are randomly assigned to one of two groups one continues their conventional glucocorticoid therapy, while the other receives dual-release hydrocortisone tablets once daily while fasting. The dose of hydrocortisone remains the same as before entering the trial. The dual-release formulation is designed to better mimic the bodys natural cortisol rhythm, potentially reducing adverse effects seen with current treatments. Throughout the study, participants are monitored regularly with various assessments including cholesterol levels, blood sugar, BMI, blood pressure, hormone levels, bone density, quality of life surveys, sexual function evaluations, and mental health status. These measurements are taken at the start and at 6, 12, and 24 months to track changes over time. Safety is also monitored by recording any adverse events. The study duration allows researchers to observe both short- and long-term effects of the treatments.

Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment