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:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT07247058
Eligibility Criteria:
Inclusion Criteria:
* Adults aged ≥18 years.
* Diagnosis of mild autonomous cortisol secretion (MACS) defined by:
* Serum cortisol \>1.8 µg/dL after 1 mg overnight dexamethasone suppression test (DST).
* Presence of adrenal adenoma confirmed by imaging (CT or MRI).
* Ability to provide informed consent.
* Willingness to undergo study procedures including DEXA scan and laboratory assessments.
Exclusion Criteria:
* Known diagnosis of Cushing's syndrome or overt hypercortisolism.
* Current or recent (within 3 months) treatment with glucocorticoids or medications affecting cortisol production (e.g., ketoconazole, metyrapone).
* Severe hepatic impairment or renal failure.
* Pregnancy or breastfeeding.
* Known allergy or contraindication to osilodrostat (Isturisa).
* Participation in another interventional clinical trial within the last 30 days.
* Any medical or psychiatric condition that, in the investigator's judgment, may interfere with study participation or safety.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07247058
Study Brief:
Protocol Section:
NCT07247058