Status:
RECRUITING
Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment
Lead Sponsor:
Federico II University
Conditions:
Congenital Adrenal Hyperplasia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a controlled, open study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on clinical, anthropometric parameters, metaboli...
Detailed Description
Congenital adrenal hyperplasia due to 21-hydroxylase deficiency is an autosomal recessive disorder characterized by cortisol and in some cases aldosterone deficiency, associated with androgen excess. ...
Eligibility Criteria
Inclusion
- males and females aged \>18 years;
- established diagnosis of adrenal insufficiency in congenital adrenal hyperplasia due to 21-hydroxylase deficiency;
- stably treated with conventional glucocorticoids, available to change their regimen according to random allocation
- written informed consent/assent to participate in the study in compliance with local regulations.
Exclusion
- clinical or laboratory signs of severe cerebral, respiratory, hepatobiliary or pancreatic diseases, renal dysfunction, gastrointestinal emptying, or motility disturbances (i.e. chronic diarrhea), significant psychiatric illnesses;
- history of/or current alcohol and/or drug abuse;
- night shift workers;
- underlying diseases that could necessitate treatment with glucocorticoids;
- therapies with hepatic enzyme induction drugs interfering with glucocorticoid kinetics, or immunosuppressive steroid therapy;
- patients with a documented intolerance/known hypersensitivity to dual release hydrocortisone;
- vulnerable populations, such as elderly, cancer patients, pregnant and lactating women;
- history of non-compliance to medical regimens, or potentially unreliable patients
Key Trial Info
Start Date :
August 11 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03760835
Start Date
August 11 2016
End Date
December 31 2027
Last Update
September 16 2025
Active Locations (1)
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1
Federico II University
Naples, Italy, 80131