ClinicalTrials.gov record NCT03760835

Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 4A study of a treatment that is already approved, to learn more about its long-term effects, safety or use in everyday practice.
Age18 years old and older
SexAll
LocationItaly
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, open-label Phase 4 trial compares once-daily dual-release hydrocortisone (Plenadren) with participants' usual conventional glucocorticoid regimen in adults with congenital adrenal hyperplasia due to 21-hydroxylase deficiency. The dual-release tablet is given once each morning in the fasting state and the daily dose is kept the same as before randomization. Participants are followed during routine clinical care with measurements at baseline, 6, 12, and 24 months.

What it is studying. The study tests the effects of switching from conventional (immediate-release) glucocorticoid treatment to a once-daily dual-release hydrocortisone tablet on metabolic measures, hormonal control, bone density, quality of life, reproductive and sexual function, psychological status, and treatment compliance in adults with CAH due to 21-hydroxylase deficiency.

What the researchers hope to learn. To compare dual-release hydrocortisone versus conventional glucocorticoids on clinical and metabolic outcomes, hormonal control, bone status, quality of life, reproductive and sexual function, psychological measures, and treatment compliance in adults with CAH. The primary outcome listed is change in total and LDL cholesterol over time.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

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

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Congenital adrenal hyperplasia due to 21-hydroxylase deficiency is an autosomal recessive disorder characterized by cortisol and in some cases aldosterone deficiency, associated with androgen excess. Treatment goals are to replace cortisol deficiency, to control androgen levels, while avoiding the adverse effects of exogenous glucocorticoids. A variety of glucocorticoid treatments have been used in an attempt to control the overnight increase in adrenal androgens. However, there is no consensus on the optimum management of congenital adrenal hyperplasia adults. Current evidence in patients with adrenal insufficiency suggests that the inability of current regimens to replace physiological circadian cortisol levels, leads to adverse clinical outcomes, including metabolic syndrome, insulin resistance, increased risk factors for cardiovascular diseases, bone and immune alterations, sleep disturbances and quality of life impairment. Moreover, the risk for poor treatment compliance, in case of multiple daily doses treatment regimens, should not be excluded. In this trial a dual-release hydrocortisone preparation, that been able to mimic the circadian pattern of circulating cortisol, was studied in patients with adrenal insufficiency due to congenital adrenal hyperplasia. All patients with a diagnosis of congenital adrenal hyperplasia due to 21-hydroxylase deficiency, irrespective of glucocorticoid treatment, are eligible for the inclusion in the study and may be asked to participate in the study. Patients are followed during the course of routine clinical practice for the duration of time that the study is active. ARM1: Conventional glucocorticoid therapy is continued as before entering the study ARM2: Dual release hydrocortisone oral tablets is administered once-daily in the fasting state. The dose is kept the same as patients had before entering the trial.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomized to either continue their usual glucocorticoid treatment or switch to once‑daily dual‑release hydrocortisone (taken fasting) at the same total daily dose. They will be followed as part of routine clinical visits with assessments at baseline, 6, 12 and 24 months. Assessments include blood tests, bone density scan (DEXA), questionnaires about quality of life, sexual function and mood, semen analysis for men, ultrasound assessment of ovarian follicles for women, and safety monitoring for adverse events. The study involves changing or continuing medication per assignment and regular follow-up visits with testing.

How the study is structured. Interventional, randomized, parallel-group, open-label Phase 4 trial. Adults are assigned to either continue their usual conventional glucocorticoid treatment or switch to once-daily dual-release hydrocortisone (taken fasting) at the same total daily dose. Outcomes (including cholesterol, blood sugar, BMI, blood pressure, bone density, questionnaires on quality of life and sexual function, and hormone measures) are recorded at baseline and at 6, 12, and 24 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on congenital adrenal hyperplasia

Clinical trials43 trials listed for congenital adrenal hyperplasiaEvery trial the registry lists for congenital adrenal hyperplasia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in congenital adrenal hyperplasia researchLatest monthly update: September 2026. Includes: Bedtime hydrocortisone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Aug 11, 2016
Primary completion
Dec 31, 2026 (estimated)
Study completion
Dec 31, 2027 (estimated)
Target enrollment
150 participants (estimated)
Last updated on registry
Sep 16, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Federico II University
Principal investigator
Prof. Rosario Pivonello, Full Professor
Federico II University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Federico II UniversityRecruiting

    Naples, 80131 · Italy

Terms used on this page · explanations by MedicalUpdates.ai

glucocorticoid
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
allocation
How participants are assigned to study groups, for example at random or by a non-random rule.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
assent
A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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