Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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, 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federico II University
• Treatments: Cortisol succinate; Cortisone; Cortisone acetate; Dexamethasone; Epinephrine; Epinephryl borate; Glucocorticoids; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Prednisolone; Prednisone; Racepinephrine

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