Actively Recruiting
Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
Led by Marianne Christina Klose · Updated on 2026-03-16
250
Participants Needed
3
Research Sites
299 weeks
Total Duration
On this page
Sponsors
M
Marianne Christina Klose
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this double-blinded randomised placebo-controlled clinical trial, the aim is to determine the effect of supplemental hydrocortisone compared with placebo during mild to moderate physical or mental stress on health related quality of life in patients with polymyalgia rheumatica (PMR)/giant cell arteritis (GCA) on ongoing low-dose prednisolone diagnosed with glucocorticoid-induced adrenal insufficiency. The main emphasis is on fatigue (primary outcome) and daily variation hereof during periods of stress.
CONDITIONS
Official Title
Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Women must be postmenopausal (FSH measured at screening)
- Diagnosis of polymyalgia rheumatica (PMR) and/or giant cell arteritis (GCA)
- Prednisolone treatment for at least 12 weeks
- Ongoing prednisolone treatment with a daily dose greater than 0 mg and up to 5 mg, stable for at least 2 weeks before screening
You will not qualify if you...
- Known primary or secondary adrenal insufficiency
- Known Cushing's Syndrome
- Allergy to any ingredients in the study medications
- Severe comorbidities including heart failure (NYHA class IV), kidney failure (eGFR <30 mL/min), liver cirrhosis, active cancer, or severe immune deficiency
- History of psychiatric disease requiring treatment by a psychiatric department within the last year (affective disorders only)
- Alcohol consumption exceeding 21 units per week
- Planned major surgery during the study period
- Use of drugs affecting cortisol metabolism or measurements, including systemic estrogen treatment discontinued less than 1 month before inclusion, strong CYP3A4 inhibitors or inducers, or other glucocorticoid formulations except permitted ones
- Inability to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Department of Endocrinology, Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
2
Department of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
3
Department of Endocrinology, Odense University Hospital
Odense, Denmark
Actively Recruiting
Research Team
M
Marianne Klose, MD, PhD
CONTACT
S
Stina W. Borresen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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