Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT02282150
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with adrenal insufficiency due to hypopituitarism
* In steady twice or thrice daily (10-40 mg) hydrocortisone replacement treatment
* Written informed consent
* For women: Use of reliable methods of contraception in clinical trials in accordance with the definition by the Danish Health and Medicines Authority; intrauterine devices or hormonal methods (oral contraceptives, contraceptive implants, transdermal patches, hormonal vaginal devices or injections with prolonged release).
Exclusion Criteria:
* Pregnancy
* Breast feeding
* Acromegaly
* Cushing's Disease
* Diabetes Mellitus
* Other major confounding disease
* Known or expected hypersensitivity to any of the excipients
* Lack of compliance (attendance and medication)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02282150
Study Brief:
Protocol Section:
NCT02282150