Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment
ConditionCongenital Adrenal Hyperplasia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFederico II University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone)
DrugTreatment of congenital adrenal hyperplasia
Dual release hydrocortisone (plenadren)
DrugTreatment of congenital adrenal hyperplasia
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Dual-release hydrocortisoneExperimental treatment 2 interventions
Group B: Conventional glucocorticoidsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in measurement of total and LDL cholesterol (mg/dl)
Single outcome measurement of cholesterol levels (mg/dl)
Time frame
0, + 6 months, + 12 months, +24 monthsSecondary outcomes
1
Change from baseline in measurement of glycaemia (mg/dl)
Measure of glycaemia (mg/dl)
Time frame
0, + 6 months, + 12 months, +24 months2
Change from baseline in measurement of BMI (Kg/m2)
Measure of BMI (Kg/m2)
Time frame
0, + 6 months, + 12 months, +24 months3
Change from baseline in measurement of blood pressure (mmHg)
Measure of blood pressure (mmHg)
Time frame
0, + 6 months, + 12 months, +24 months4
Change from baseline in measurement of insulinemia (μU/mL)
Measure of insulinemia (μU/mL)
Time frame
0, + 6 months, + 12 months, +24 monthsSponsors and contacts
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Source ClinicalTrials.gov