The CORTAD study
- Conditions
- Primary adrenal insufficiency (PAI)Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- CTIS2024-512888-31-00
- Lead Sponsor
- Helse Bergen HF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 50
Age 16-80 years, Established PAI according to the diagnostic criteria as specified above., Participants must be recently diagnosed, specifically treated with glucocorticoid replacement therapy for less than 31 days prior to inclusion to secure treatment naivety., Women of childbearing potential (WOCBP) must have a negative pregnancy test performed at the time of screening., Participants must be capable of giving signed informed consent
High dose glucocorticoid therapy for other disease during last three months prior to screening., Ongoing treatment for active malignant disease., Severe hepatic or renal disease., Sever psychiatric disease., Chronic abuse of alcohol or drug abuse., Current pregnancy, and if the participant plan to become pregnant during the 12 months of study participation., Known hypersensitivity to the active substance or any of the excipients., Participation in another blinded clinical study involving an investigational medicinal product within 1 month prior to study inclusion.
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