Once-daily dual-release hydrocortisone for adults with congenital adrenal hyperplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open, controlled Phase 4 study compares a dual-release hydrocortisone formulation (Plenadren) given once daily with conventional immediate-release glucocorticoid regimens in adults with 21-hydroxylase congenital adrenal hyperplasia. Participants are switched or randomized from their usual therapy and followed for clinical, anthropometric, metabolic, hormonal, bone, reproductive/sexual, psychological, and quality-of-life outcomes as well as treatment compliance. The rationale is that the dual-release formulation better mimics the normal circadian cortisol rhythm and may reduce the adverse metabolic and quality-of-life effects seen with non-physiological dosing. Safety, tolerability, and effects on androgen control are key measured endpoints.

Why it matters

Who can join: the full rules

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

Where it's running

• Federico II University
  Naples, Italy Recruiting

Study contacts

• Study coordinator: Rosario Pivonello, M.D., PhD, Professor
• Email: rosario.pivonello@unina.it
• Phone: +390817464983

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.