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New treatment option for Adrenal Insufficiency
Official title Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
ClinicalTrials.gov ID: NCT05435781
What this study is testing
What is Hydrocortisone?
Hydrocortisone is an investigational medicine, given as an once-daily, being studied as a potential treatment for adrenal insufficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Age ≥ 50 years
- Women must be postmenopausal (FSH is measured at the screening visit)
- A diagnosis of PMR/GCA, or both conditions combined.
- Treatment with prednisolone ≥12 weeks
- Ongoing prednisolone treatment, with current daily prednisolone dose \> 0 mg and ≤5 mg. The dose must have been ≤5 mg for minimum 2 weeks at the time...
You likely can't join if
- Known primary or secondary adrenal insufficiency
- Known Cushing's Syndrome
- Known allergy towards study medication ingredients
- Severe comorbidity: Heart failure (New York Heart Association class IV); Kidney failure with an estimated glomerular filtration rate \<30 mL/min...
- Alcohol consumption \>21 units per week
- Planned major surgery during the study period at study entry.
See the full eligibility criteria
- Age ≥ 50 years
- Women must be postmenopausal (FSH is measured at the screening visit)
- A diagnosis of PMR/GCA, or both conditions combined.
- Treatment with prednisolone ≥12 weeks
- Ongoing prednisolone treatment, with current daily prednisolone dose \> 0 mg and ≤5 mg. The dose must have been ≤5 mg for minimum 2 weeks at the time of the screening visit.
- Known primary or secondary adrenal insufficiency
- Known Cushing's Syndrome
- Known allergy towards study medication ingredients
- Severe comorbidity: Heart failure (New York Heart Association class IV); Kidney failure with an estimated glomerular filtration rate \<30 mL/min (Chronic kidney disease stage 4-5); Liver disease in the form of...
- 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 (discontinued \< 1 month before inclusion), Treatment with strong CYP3A4 inhibitors or inducers, Use of other...
- Inability to provide written informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Copenhagen, Denmark
- Odense, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Copenhagen, Denmark; Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.