💬In plain words
What the trial is, and whether it could suit you
Drug interventional, controlled, randomized open-label, parallel-group, multicenter study in patients with bilateral adrenal incidentalomas associated with subclinical Cushing's syndrome
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
Inclusion criteria - run-in (phase 1)
* Unilateral or bilateral adrenal nodules with benign features associated with thickening of the adrenal arms \>5 mm on abdominal CT scan
* SCS (detected 2 times in the 6 months before run-in) defined by the absence of catabolic signs of Cushing's syndrome in association with any of these 3 conditions:
* 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
* Hypertension (BP ≥140/90 mmHg and/or ongoing antihypertensive treatment)
* Patients who cannot undergo surgery
* Acquisition of informed consent.
Inclusion criteria - randomization (phase 2)
\- BP \>100/60 mmHg and \<130/85 mmHg on antihypertensive therapy (lowest effective dose) within 6-10 months after enrollment.
Exclusion Criteria:
* 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
* Taking medications known to interfere with Metirapone
* Known or suspected hypersensitivity to the drug or drug class under study
* Patients with serious clinical conditions that, in the opinion of the Investigator, contraindicate the patient's participation in the study
* Patients with primary corticosurrenal insufficiency, impaired adrenal secretion, and severe hypopituitarism
* Patients with impaired liver function
* Patients with untreated hypothyroidism or being treated with drugs that have an action on the hypothalamic-pituitary-adrenal axis
* Patients with hypersensitivity to the active ingredient or any of the excipients listed in section 6.1 of the RCP - Metirapone.