Actively Recruiting
Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment
Led by Federico II University · Updated on 2025-09-16
150
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 body's 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.
CONDITIONS
Brief Title
Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged over 18 years
- Established diagnosis of adrenal insufficiency in congenital adrenal hyperplasia due to 21-hydroxylase deficiency
- Stably treated with conventional glucocorticoids and able to change treatment according to random allocation
- Provided written informed consent to participate in the study following local regulations
You will not qualify if you...
- Severe brain, respiratory, liver, pancreas, kidney, or digestive diseases including chronic diarrhea
- Significant psychiatric illnesses
- History or current alcohol and/or drug abuse
- Night shift workers
- Diseases requiring glucocorticoid treatment
- Use of hepatic enzyme induction drugs or immunosuppressive steroid therapy
- Known intolerance or hypersensitivity to dual release hydrocortisone
- Vulnerable populations such as elderly, cancer patients, pregnant or breastfeeding women
- History of non-compliance or unreliable patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive either conventional glucocorticoids or dual-release hydrocortisone once daily to manage congenital adrenal hyperplasia.
Visits at baseline, 6 months, 12 months, and 24 months for assessments
Trial Site Locations
Total: 1 location
1
Federico II University
Naples, Italy, 80131
Actively Recruiting
Research Team
R
Rosario Pivonello, M.D., PhD, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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