Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment

NCT03760835 | Recruiting Phase 4

• 1 other identifier: 140/16
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Adrenal Hyperplasia

Keywords

congenital adrenal hyperplasia; glucocorticoid treatment; dual release hydrocortisone

Outcome Measures

Primary Outcomes (1)

• Change from baseline in measurement of total and LDL cholesterol (mg/dl)

  Single outcome measurement of cholesterol levels (mg/dl)

  0, + 6 months, + 12 months, +24 months

Secondary Outcomes (16)

• Change from baseline in measurement of glycaemia (mg/dl)

  0, + 6 months, + 12 months, +24 months

• Change from baseline in measurement of BMI (Kg/m2)

  0, + 6 months, + 12 months, +24 months

• Change from baseline in measurement of blood pressure (mmHg)

  0, + 6 months, + 12 months, +24 months

• Change from baseline in measurement of insulinemia (μU/mL)

  0, + 6 months, + 12 months, +24 months

• Change from baseline in measurement of triglycerides (mg/dl)

  0, + 6 months, + 12 months, +24 months

Study Arms (2)

Dual-release hydrocortisone

EXPERIMENTAL

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

Conventional glucocorticoids

ACTIVE COMPARATOR

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

Interventions

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

Treatment of congenital adrenal hyperplasia

Conventional glucocorticoids; Dual-release hydrocortisone

Dual release hydrocortisone (plenadren) DRUG

Treatment of congenital adrenal hyperplasia

Dual-release hydrocortisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital

Interventions

Cortisone; Prednisone; Prednisolone; Dexamethasone

Condition Hierarchy (Ancestors)

Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienediols; Pregnadienes; Pregnadienetriols; Steroids, Fluorinated

Central Study Contacts

Rosario Pivonello, M.D., PhD, Professor

CONTACT

+390817464983; rosario.pivonello@unina.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 30, 2018
• Study Start: August 11, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)