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Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment

Study acronym: CareOnTIME
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion date: Dec 31, 2023 to Dec 31, 2026
    • Study completion date: Dec 31, 2023 to Dec 31, 2027
    • Secondary endpoints: 17 to 16
    v5
  2. Primary and study completion dates: Dec 31, 2021 to Dec 31, 2023v4
  3. Secondary endpoints: details revised at 1 of 17 entriesv3
  4. Primary endpoint revised
    • Secondary endpoints revised (17)
    • Study title expanded, about 1 word
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03760835
Lead Sponsor Federico II University
Conditions
(from sponsor)		 Congenital Adrenal Hyperplasia
Related terms Adrenal Hyperplasia, Congenital
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov