Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT03760835
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03760835
Study Brief:
Protocol Section:
NCT03760835