Hydrocortisone Versus Methylprednisolone for the Treatment of Glucocorticoid-Induced Adrenal Insufficiency
Starting soon · Phase 4
Conditions studied: Adrenal Insufficiency
In brief
This study aims to compare the use of methylprednisolone and hydrocortisone as replacement therapies in patients with glucocorticoid-induced adrenal insufficiency. The primary goal is to evaluate and compare the recovery of the hypothalamic-pituitary-adrenal (HPA) axis.
Key facts
- Study ID
- NCT07703098
- Run by
- University Medical Centre Ljubljana
- People needed
- 66
- Starts
- 2026-09-01
- Expected to finish
- 2030-09-01
- Last updated by the study team
- 2026-07-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age over 18 years.
- Suspected adrenal insufficiency due to receiving supraphysiological doses of methylprednisolone for more than 4 weeks.
- Receiving methylprednisolone 4 mg for at least the last 4 weeks.
- Morning cortisol lower than 300 nmol/L.
- Inadequate result of a short ACTH test performed on a physiological dose of methylprednisolone (cortisol rise after 30 min under 470 nmol/L AND after 60 min under 500 nmol/L).
- No further indication for treating the underlying disease, and retreatment with glucocorticoids is not expected in the next 2 years.
- Consent to participate in the research.
You may not qualify if…
- Known organic disease of the pituitary-adrenal axis.
- Body mass over 130 kg.
- Advanced comorbidities.
- Advanced heart failure (NYHA IV).
- Chronic kidney disease IV, eGFR under 30 ml/min.
- Liver cirrhosis.
- Active malignant disease.
- Immune deficiencies.
- Planned major surgery during the study duration.
- Receiving drugs affecting cortisol metabolism or interfering with cortisol measurements (e.g., systemic estrogens, strong inducers or inhibitors of CYP3A4).
- Conditions affecting cortisol metabolism (pregnancy, liver disease, nephrotic syndrome).
- Alcohol dependence syndrome (consuming more than 21 units of alcohol per week).
- Shift (night) work.
- Presence of comorbidities with an expected life expectancy of less than 3 years.
Where it is running
- UMC Ljubljana — Ljubljana, Slovenia
Full record on ClinicalTrials.gov
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