Status:
RECRUITING
Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment
Lead Sponsor:
Marianne Andersen
Collaborating Sponsors:
Aarhus University Hospital
Copenhagen University Hospital, Denmark
Conditions:
Adrenal Insufficiency
Polymyalgia Rheumatica (PMR)
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
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 tr...
Eligibility Criteria
Inclusion
- Age ≥ 50 years
- A diagnosis of PMR or GCA in GC free remission for \>2 week and \<12 weeks after treatment with prednisolone (any dosage) for ≥12 weeks
Exclusion
- Known primary or secondary adrenal insufficiency
- Known Cushing´s syndrome
- Heart failure (New York Heart Association class IV)
- Kidney failure with an estimated glomerular filtration rate \<30 mL/min
- Liver cirrhosis
- Active cancer
- Known severe immune deficiency
- A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry)
- Alcohol consumption \>21 units per week
- Planned major surgery during the study period at study entry
- Use of drugs that interfere with cortisol metabolism/measurements:
- Systemic oestrogen treatment within 1 month before study inclusion
- Strong CYP3A4 inhibitors or inducers
- Use of other glucocorticoid formulations: inhaled, intra-articular or intramuscular injections, creams European steroid group IV applied in genital area
- Permitted glucocorticoid formulations: eye-drops, nasal spray, creams European group I-III, and European group IV applied in non-genital area
- Inability to provide written informed consent
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05193396
Start Date
February 1 2022
End Date
January 1 2026
Last Update
December 22 2025
Active Locations (3)
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1
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, Denmark
2
Department of Nephrology and Endocrinology, Rigshospitalet
Copenhagen, Denmark
3
Department of Endocrinology, Odense University Hospital
Odense, Denmark, 5230