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CUSHMAH - Benefit of steroidogenesis inhibitors in Mild Cushing syndrome (Mild Autonomous Cortisol Secretion): a randomized trial in patients with Primary Bilateral Macronodular Adrenocortical Hyperplasia

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507010-27-00
Enrollment
70
Registered
2026-03-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Bilateral Macronodular Adrenal Hyperplasia causing moderate Cushing Syndrome (Mild autonomous Cortisol secretion)

Brief summary

At 6 months of treatment number of patients achieving: 1) improvement of blood pressure control and/or 2) improvement of diabetes

Detailed description

Change of urinary cortisol, salivary cortisol during the circadian rhythm, steroid profile (mass spectrometry analysis) and morning ACTH plasma level at M0, M3 and M6, Evolution of Body Mass Index, insulin sensitivity as determined by HOMA, glycemia as determined by glucose continuous monitoring, total cholesterol, HDL, LDL, triglyceride at M0, M3 and M6, Mean change from baseline to M6 in day-time and night-time Systolic and Diastolic Blood Pressure irrespective of antihypertensive treatment adaptations, Mean change from baseline to M6 in HbA1c irrespective of antidiabetic treatment adaptations, Change in the score of the 3 following quality of life and depression questionnaires at M0, M3 and M6: Medical Outcomes Study 36-item short-form health survey (SF-36), the Beck depression inventory (BECK BDI-II) and the QolCushing, Comparaison of the hormonal and clinical response according to the ARMC5, PDE11A4 and NR3C1 genotypes., Collecting data on adverse events

Interventions

DRUGMETYRAPONE ESTEVE 250 mg
DRUGPlacebo of metyrapon 250 mg

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
At 6 months of treatment number of patients achieving: 1) improvement of blood pressure control and/or 2) improvement of diabetes

Secondary

MeasureTime frame
Change of urinary cortisol, salivary cortisol during the circadian rhythm, steroid profile (mass spectrometry analysis) and morning ACTH plasma level at M0, M3 and M6, Evolution of Body Mass Index, insulin sensitivity as determined by HOMA, glycemia as determined by glucose continuous monitoring, total cholesterol, HDL, LDL, triglyceride at M0, M3 and M6, Mean change from baseline to M6 in day-time and night-time Systolic and Diastolic Blood Pressure irrespective of antihypertensive treatment adaptations, Mean change from baseline to M6 in HbA1c irrespective of antidiabetic treatment adaptations, Change in the score of the 3 following quality of life and depression questionnaires at M0, M3 and M6: Medical Outcomes Study 36-item short-form health survey (SF-36), the Beck depression inventory (BECK BDI-II) and the QolCushing, Comparaison of the hormonal and clinical response according to the ARMC5, PDE11A4 and NR3C1 genotypes., Collecting data on adverse events

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 6, 2026