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Clinical Trials in Italy / NCT03760835
Recruiting Phase 4

Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment

NCT03760835 · tracked via the Priya Life Science Italy tracker
Sponsor
Federico II University
Phase
Phase 4
Started
2016-08-11
Last updated
2025-09-16

Condition(s) studied

Congenital Adrenal Hyperplasia

Investigational drug(s) / intervention(s)

Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone)Dual release hydrocortisone (plenadren)

Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone): Treatment of congenital adrenal hyperplasia

Dual release hydrocortisone (plenadren): Treatment of congenital adrenal hyperplasia

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change from baseline in measurement of total and LDL cholesterol (mg/dl) — 0, + 6 months, + 12 months, +24 months
    Single outcome measurement of cholesterol levels (mg/dl)

Trial sites (1)

FacilityCityRegionStatus
Federico II University Naples Italy Recruiting

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Other trials for the same condition

A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia Recruiting
Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia Active, not recruiting
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH) Recruiting
An Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia Recruiting
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03760835 on ClinicalTrials.gov ↗ ← All trials in Italy