Clinical Trial

Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment

Study acronym: CareOnTIME
Recruiting Phase 4
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2018-11-29; most recent amendment 2025-09-10.
Trial Details
NCT Number NCT03760835
Lead Sponsor Federico II University
Conditions Congenital Adrenal Hyperplasia
Enrollment 150 participants
Start Date 2016-08-11
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-16