Glucocorticoid Replacement in Addison's disease
- Conditions
- Autoimmune Addison's disease is a rare and chronic disease wich leads to primary adrenal failure. The conventional glucocorticoid replacement therapy in primary adrenal insufficiency (Addison’s disease) renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. In this study we will include patients with Addison's disease to explore if more physiological glucocorticoid treatment could improve health for the patients.MedDRA version: 9.1Level: LLTClassification code 10001130Term: Addison's disease
- Registration Number
- EUCTR2009-010917-61-SE
- Lead Sponsor
- Haukeland University hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Patients with verified primary adrenal insufficiency (Addison’s disease) will be included. In case of concomitant endocrine/autoimmune diseases these should be on stable treatment during the study period. The patient will have to give written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients with diabetes mellitus on insulin treatment will not be included in this study. Other exclusion criteria are cardiovascular disease, malignant disease and pregnancy, and pharmacological treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St Johns wart). The patients should not take grapefruit juice the last two weeks before or during the study period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method