RecruitingPhase 4NCT03760835

Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment

Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment

Sponsor

Federico II University

Enrollment

150 participants

Start Date

Aug 11, 2016

Study Type

INTERVENTIONAL

Conditions

Congenital Adrenal Hyperplasia

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria8

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