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New treatment option for Adrenal Insufficiency
Official title Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment
ClinicalTrials.gov ID: NCT05193396
What this study is testing
What is Hydrocortisone?
Hydrocortisone is an investigational medicine, given as an once-daily pill taken by mouth, 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
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
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.