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Study identifier: NCT05193396 Synced from ClinicalTrials.gov · July 29, 2026
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Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment

Condition: Adrenal Insufficiency · Polymyalgia Rheumatica (PMR) · Giant Cell Arteritis (GCA)  ·  Sponsor: Marianne Andersen

PhasePhase 4
Planned participants100
Who can joinAll sexes, 50 Years to no upper limit
Healthy volunteersNo

About this study

Cortisol, a glucocorticoid (GC) hormone secreted from the adrenal glands, is essential for survival. Cortisol also possesses anti-inflammatory actions and GC formulations (prednisolone) are used to treat many inflammatory diseases and conditions. Indeed, three percent of the Danish population (≈ 180.000 individuals) redeems at least one prescription of synthetic GC per year and at least 20,000 patients annually discontinue GC treatment. Pharmacological GC therapy suppresses endogenous cortisol production and thereby induce relative adrenal insufficiency (GIA). The risk of GIA as determined by the adrenal corticotrophic hormone (ACTH) stimulation test has previously been reported to ≈ 25 %, but testing after GC treatment is not routinely performed. Indeed, new evidence suggest that the risk of GIA after planned cessation of prednisolone treatment for polymyalgia rheumatic (PMR) or giant cell arteritis (GCA) is substantially lower, probably 2%. The reason for this discrepancy is undoubtedly selection bias in the previous publications and the use of inaccurate cortisol assays. At the same time, however, it was observed that 25% exhibited pronounced symptoms of adrenal insufficiency based on a questionnaire specific for detecting symptoms of adrenal insufficiency, the so-called AddiQoL-30. Concomitantly, the basal cortisol levels in the same group were significantly lower as compared to the group, who exhibited milder or no symptoms attributable to adrenal insufficiency. This obs…

This description comes directly from the study's public registry record.

Talk to the study team

Marianne S Andersen  ·  +4565411807  ·  marianne.andersen1@rsyd.dk

Always discuss trial participation with your own doctor first.

Locations (3)

Department of Endocrinology and Internal Medicine, Aarhus University HospitalAarhus, DenmarkRecruiting
Department of Nephrology and Endocrinology, RigshospitaletCopenhagen, DenmarkRecruiting
Department of Endocrinology, Odense University HospitalOdense, DenmarkRecruiting

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Source record: clinicaltrials.gov/study/NCT05193396