Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 4 April 2022
• Main ID: NCT03760835
• Date of registration: 09/11/2018
• Prospective Registration: No
• Primary sponsor: Federico II University
• Public title: Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment CareOnTIME
• Scientific title: Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment
• Date of first enrolment: August 11, 2016
• Target sample size: 150
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03760835
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Italy

Contacts

• Name: Rosario Pivonello, MD,PhD,Professor

• Name: Rosario Pivonello, M.D., PhD, Professor

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Congenital Adrenal Hyperplasia

Intervention(s)

Drug: Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone)

Drug: Dual release hydrocortisone (plenadren)

Primary Outcome(s)

Change from baseline in measurement of total and LDL cholesterol (mg/dl) [Time Frame: 0, + 6 months, + 12 months, +24 months]

Secondary Outcome(s)

Changes in ovarian follicles reserve [Time Frame: 0, + 6 months, + 12 months, +24 months]

Changes in depression status [Time Frame: 0, + 6 months, + 12 months, +24 months]

Change from baseline in measurement of Glycated Haemoglobin (%) [Time Frame: 0, + 6 months, + 12 months, +24 months]

Change from baseline in measurement of triglycerides (mg/dl) [Time Frame: 0, + 6 months, + 12 months, +24 months]

Changes in treatment compliance [Time Frame: 0, + 6 months, + 12 months, +24 months]

Change from baseline in measurement of blood pressure (mmHg) [Time Frame: 0, + 6 months, + 12 months, +24 months]

Change from baseline in measurement of BMI (Kg/m2) [Time Frame: 0, + 6 months, + 12 months, +24 months]

Change from baseline in measurement of HDL-cholesterol (mg/dl) [Time Frame: 0, + 6 months, + 12 months, +24 months]

Changes in quality of life [Time Frame: 0, + 6 months, + 12 months, +24 months]

Incidence of Treatment Adverse Events (safety analysis) [Time Frame: 0, + 6 months, + 12 months, +24 months]

Change from baseline in measurement of glycaemia (mg/dl) [Time Frame: 0, + 6 months, + 12 months, +24 months]

Changes in androgens levels [Time Frame: 0, + 6 months, + 12 months, +24 months]

Change from baseline in measurement of insulinemia (µU/mL) [Time Frame: 0, + 6 months, + 12 months, +24 months]

Changes in sex function in females [Time Frame: 0, + 6 months, + 12 months, +24 months]

Changes in bone mineral density [Time Frame: 0, + 12 months, +24 months]

Changes in sex function in males [Time Frame: 0, + 6 months, + 12 months, +24 months]

Changes in sperm concentration [Time Frame: 0, + 6 months, + 12 months, +24 months]

Secondary ID(s)

140/16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors