Actively Recruiting
Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment
Led by Federico II University · Updated on 2025-09-16
150
Participants Needed
1
Research Sites
594 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a controlled, open study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on clinical, anthropometric parameters, metabolic syndrome, hormonal profile, bone status, quality of life, reproductive, sexual and psychological functions and treatment compliance in patients affected by congenital adrenal hyperplasia due to 21 OH deficiency.
CONDITIONS
Official 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
- Confirmed diagnosis of adrenal insufficiency due to congenital adrenal hyperplasia from 21-hydroxylase deficiency
- Stable treatment with conventional glucocorticoids and willingness to change treatment as assigned
- Written informed consent to participate according to local rules
You will not qualify if you...
- Severe brain, respiratory, liver, pancreatic, kidney, or digestive diseases, including chronic diarrhea, or major psychiatric disorders
- History or current use of alcohol or drug abuse
- Night shift workers
- Other diseases requiring glucocorticoid treatment
- Use of drugs that affect glucocorticoid metabolism or immunosuppressive steroids
- Known allergy or intolerance to dual-release hydrocortisone
- Vulnerable groups including elderly, cancer patients, pregnant or breastfeeding women
- History of poor compliance or unreliable patients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Federico II University
Naples, Italy, 80131
Actively Recruiting
Research Team
R
Rosario Pivonello, M.D., PhD, Professor
CONTACT
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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