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Taking peoplePhase 4

Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Cushing's Syndrome

Key facts

Phase
Phase 4

This trial has no sites in United States.

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Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT06801249, who can take part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Trial code
NCT06801249
Record updated
30 January 2025
Original description
Drug interventional, controlled, randomized open-label, parallel-group, multicenter study in patients with bilateral adrenal incidentalomas associated with subclinical Cushing's syndromeRead full original descriptionShow less

"Effect of Metyrapone on Cardiovascular Risk Factors in Patients With Adrenal Incidentalomas and Subclinical/Mild Cushing's Syndrome

Drug interventional, controlled, randomized open-label, parallel-group, multicenter study in patients with bilateral adrenal incidentalomas associated with subclinical Cushing's syndrome

Inclusion: 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; BP >100/60 mmHg and <130/85 mmHg on antihypertensive therapy (lowest effective dose) within 6-10 months after enrollment.

Exclusion: Treatment with steroids in the last year before enrollment; Taking medications known to interfere with Metirapone; Patients with untreated hypothyroidism or being treated with drugs that have an action on the hypothalamic-pituitary-adrenal axis; 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 hypersensitivity to the active ingredient or any of the excipients listed in section 6.1 of the RCP - Metirapone; 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); Body mass index ≥40 kg/m2; Patients with impaired liver function.

ClinicalTrials.gov NCT06801249