About this trial
Drug interventional, controlled, randomized open-label, parallel-group, multicenter study in patients with bilateral adrenal incidentalomas associated with subclinical Cushing's syndrome
Eligibility criteria
Qualifiers
Unilateral or bilateral adrenal nodules with benign features associated with thickening of the adrenal arms >5 mm on abdominal CT scan
Cortisol levels after dexamethasone 1 mg test >50 nmol/L associated with baseline ACTH <10 pg/mL
Cortisol levels after dexamethasone 1 mg test >50 nmol/L associated with increased nocturnal (11 pm) salivary cortisol
Cortisol levels after dexamethasone 1 mg test >138 nmol/L
Disqualifiers
Body mass index ≥40 kg/m2
Pregnant or lactating women; diagnosis of pregnancy will be made by serum β-HCG assay
Women of childbearing age using contraceptive measures other than barrier contraception. Barrier contraceptive measures are: o Male or female condom with or without spermicide o Cervical cup, diaphragm or sponges with spermicide o Combination of male condom and cervical cup, diaphragm or sponges with spermicide (dual barrier methods)
Treatment with steroids in the last year before enrollment
Trial design
Treatments tested in this trial
- Metarapone
- Standardized antihypertensive therapy