[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645500":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":38,"responsibleParty":56,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":25,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":84,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University Medical Centre Ljubljana","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"patients with hydrocortisone","ACTIVE_COMPARATOR","Patients will receive 15 mg of hydrocortisone daily. The dose is split into 10 mg in the morning after breakfast and 5 mg after 6-7 hours.",[13],"Drug: Patients will receive 15 mg of hydrocortisone daily. The dose is split into 10 mg in the morning after breakfast and 5 mg after 6-7 hours.",{"label":15,"type":16,"description":17,"interventionNames":18},"patients with metylprednisolone","EXPERIMENTAL","Patients will receive 3 mg of methylprednisolone once daily. The dose is administered in the morning (1 ½ tablets of 2 mg methylprednisolone after breakfast).",[19],"Drug: Patients will receive 3 mg of methylprednisolone once daily. The dose is administered in the morning (1 ½ tablets of 2 mg Medrol after breakfast).",[21,26],{"type":22,"name":23,"description":17,"armGroupLabels":24,"otherNames":25},"DRUG","Patients will receive 3 mg of methylprednisolone once daily. The dose is administered in the morning (1 ½ tablets of 2 mg Medrol after breakfast).",[15],null,{"type":22,"name":11,"description":11,"armGroupLabels":27,"otherNames":25},[9],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Živa Dolenšek, MD","CONTACT","+38615223114","ziva.dolensek@kclj.si",{"name":35,"role":31,"phone":36,"phoneExt":25,"email":37},"Tomaž Kocjan, MD PHD","0038615223114","tomaz.kocjan@kclj.si",[39],{"facility":40,"status":25,"city":41,"state":25,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"UMC Ljubljana","Ljubljana","1000","Slovenia","SI",{"type":46,"coordinates":47},"Point",[48,49],14.50513,46.05108,{"lat":49,"lon":48},[52,55],{"name":53,"role":31,"phone":54,"phoneExt":25,"email":33},"živa dolenšek, MD","003865223114",{"name":35,"role":31,"phone":36,"phoneExt":25,"email":37},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Živa Dolenšek","MD",[61],{"name":62,"class":6},"University of Ljubljana","100645500","phase-4-hydrocortisone-versus-methylprednisolone-for-the-treatment-of-glucocorticoid-induced-adrenal-insufficiency-100645500",false,"NCT07703098","Hydrocortisone Versus Methylprednisolone for the Treatment of Glucocorticoid-Induced Adrenal Insufficiency","Inclusion Criteria:\n\n* Age over 18 years.\n* Suspected adrenal insufficiency due to receiving supraphysiological doses of methylprednisolone for more than 4 weeks.\n* Receiving methylprednisolone 4 mg for at least the last 4 weeks.\n* Morning cortisol lower than 300 nmol\u002FL.\n* Inadequate result of a short ACTH test performed on a physiological dose of methylprednisolone (cortisol rise after 30 min under 470 nmol\u002FL AND after 60 min under 500 nmol\u002FL).\n* No further indication for treating the underlying disease, and retreatment with glucocorticoids is not expected in the next 2 years.\n* Consent to participate in the research.\n\nExclusion Criteria:\n\n* Known organic disease of the pituitary-adrenal axis.\n* Body mass over 130 kg.\n* Advanced comorbidities.\n* Advanced heart failure (NYHA IV).\n* Chronic kidney disease IV, eGFR under 30 ml\u002Fmin.\n* Liver cirrhosis.\n* Active malignant disease.\n* Immune deficiencies.\n* Planned major surgery during the study duration.\n* Receiving drugs affecting cortisol metabolism or interfering with cortisol measurements (e.g., systemic estrogens, strong inducers or inhibitors of CYP3A4).\n* Conditions affecting cortisol metabolism (pregnancy, liver disease, nephrotic syndrome).\n* Alcohol dependence syndrome (consuming more than 21 units of alcohol per week).\n* Shift (night) work.\n* Presence of comorbidities with an expected life expectancy of less than 3 years.","ALL","18 Years",{"count":72,"type":73},66,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","This study aims to compare the use of methylprednisolone and hydrocortisone as replacement therapies in patients with glucocorticoid-induced adrenal insufficiency.\n\nThe primary goal is to evaluate and compare the recovery of the hypothalamic-pituitary-adrenal (HPA) axis.",[79],"Adrenal Insufficiency",[81,82,83],"hydrocortisone","Glucocorticoid-Induced Adrenal Insufficiency","methylprednisolone","NOT_YET_RECRUITING","2026-07-08",{"date":87,"type":88},"2026-07-14","ACTUAL",{"date":90,"type":73},"2026-09-01",{"date":92,"type":73},"2030-09-01",{"name":5,"class":6},1]