CUSHMAH - Benefit of steroidogenesis inhibitors in Mild Cushing syndrome (Mild Autonomous Cortisol Secretion): a randomized trial in patients with Primary Bilateral Macronodular Adrenocortical Hyperplasia
Key facts
- Phase
- Phase 3
This trial has no sites in United States.
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- Assistance Publique Hopitaux De Paris
- Trial code
- EU 2023-507010-27-00
- Record updated
- 5 March 2026
- Original description
Demonstrate that cortisol secretion inhibition by medical treatment (metyrapone) in PBMAH patients with MACS lead to improvement of hypertension and diabetes.Read full original descriptionShow less
Demonstrate that cortisol secretion inhibition by medical treatment (metyrapone) in PBMAH patients with MACS lead to improvement of hypertension and diabetes.
Inclusion: Age ≥ 18 years old; French speaking; Patient with PBMAH as determined by adrenal imaging (CT-scan and/or MRI) showing multiples bilateral supracentrimetric adrenal nodules; Mild autonomous cortisol secretion: plasma cortisol after 1 mg overnight dexamethasone test > 50 nmol/L, 24 h Urinary free cortisol < 1,5 upper limit of Normal; Adrenal origin of cortisol excess: morning plasma ACTH < 10 pg/ml or between 10 and 20 pg/ml non responsive to CRH stimulation (stimulation < 50 %); Hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) or treated hypertension and/or diabetes that can be treated with antidiabetic treatments (WHO criteria); For women of childbearing potential (WOCBP), negative bHCG and highly effective contraception; For male, an effective method of contraception; Signed a written informed consent; Affiliated to social security regime or an equivalent system.
Exclusion: Steroidogenesis inhibitor treatment less than 6 weeks before inclusion; Contraindication to steroidogenesis inhibitor; Patients with a Cushing syndrome from another causes than PBMAH; Patients with major psychiatric disorders that may interfere with the smooth running of the study; Patients with proven primary adrenal insufficiency; Hypersensitivity to the active substance or to one of its excipients; Uncontrolled diabetes (HBA1c > 9 %); Patients at high risk of cardiac rhythm disorders with QT/QTc interval > 470ms (for women) and > 450ms (for men); Drugs with a known risk of QT prolongation as listed in https://crediblemeds.org; Pregnancy or breastfeeding women; Pathology that is life-threatening in the short term (1 year); Patients on AME (state medical aid); Participation to another clinical trial on medicinal products for human use; Under glucocorticoid (systemic or high dose local) treatment; Loop diuretics and thiazide or thiazide-like diuretic that can cause hypokaliemia.