CareOnTIME.

Trial name or title	Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment (CareOnTIME).
Methods	Interventional Phase IV, open‐label RCT. Parallel design. Location: Naples, Italy. Duration: 6 months per treatment arm, but washout period was not stated in paper.
Participants	150 participants. Age: > 18 years. Gender: both genders eligible. Diagnosis: CAH due to 21‐hydroxylase deficiency.
Interventions	Arm 1: conventional glucocorticoid therapy is continued as before entering the study (immediate release HC, cortisone acetate, PD, prednisone, DXA). Arm 2: dual release HC oral tablets administered once‐daily in the fasting state.
Outcomes	Outcomes: change in LDL‐cholesterol, BMI, blood pressure, insulinaemia, glycated haemoglobin, bone mineral density, QoL, sex function in males/females, change in depression status, change in treatment compliance, changes in androgen levels, changes in sperm concentration, changes in ovarian follicle reserve.
Starting date	11 August 2016.
Contact information	Professor Rosario Pivonello, MD, PhD.
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