drugset / Trial / NCT03760835

Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment

NCT03760835

Phase 4 Recruiting 150 enrolled Federico II University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2016-08-11
Primary completion
2026-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cortisone acetate Other / unclassified
Subject Dexamethasone Small molecule
Subject Hydrocortisone Other / unclassified
Subject Hydrocortisone Other / unclassified Oral
Subject Prednisolone Other / unclassified
Subject Prednisone Other / unclassified