METYRAPONE for Adrenal incidentaloma | Subclinical Cushing's syndrome

Inclusion criteria

• {"criterion_text":"- age >18 years and <75 years\n- monolateral/bilateral nodules with benign radiological characteristics associated with enlarged adrenal limb width >5 mm at CT scan\n- SCS (absence of catabolic signs of Cushing’s syndrome) associated with at least one of the following conditions: o Cortisol after 1 mg dexamethasone suppression test >50 nmol/L and baseline ACTH <10 pg/mL o Cortisol after 1 mg dexamethasone suppression test >50 nmol/L and high salivary cortisol at 11 p.m. o Cortisol after 1 mg dexamethasone suppression test >138 nmol/L\n- Arterial hypertension (blood pressure =140/90 mmHg and/or current treatment with antihypertensive drugs)\n- Patients who are not candidate for adrenalectomy\n- BP >100/60 mmHg and <130/85 mmHg undergoing antihypertensive therapy (lowest effective dose effective dose) within 6-10 months after enrollment\n- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Body mass index =40 kg/m2\n- Pregnancy or breastfeeding\n- Women in childbearing age who do not use barrier contraceptives. Barrier contraceptives are: o male or female condom with or without spermicide o cap, diaphragm or sponge with spermicide o a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods)\n- Glucocorticoid treatment during the last year before enrollment\n- Drugs known to have interactions with Metyrapone\n- Drug allergy to Metyrapone or drugs belonging to the same class\n- Patients with severe illness\n- Patients with primary adrenal insufficiency and severe hypopituitarism\n- Patients with reduced liver function\n- Patients with untreated hypothyroidism or taking drugs acting on the hypothalamuspituitary-adrenal axis\n- Patients with drug hypersensitivity to Metyrapone or to one of the excipients listed in paragraph 6.1 of the summary of product characteristics (SPCs) – Metyrapone."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of the study is the reduction of the number and/or the dose of antihypertensive drugs after 12 months of treatment with Metyrapone, while keeping blood pressure within pre-fixed target range (>100/60 mmHg e <130/85 mmHg)","definition_or_measurement_approach":"Reduction in number and/or dose of antihypertensive drugs measured after 12 months of treatment with Metyrapone, with maintenance of blood pressure within pre-fixed target range (>100/60 mmHg and <130/85 mmHg). Blood pressure monitoring includes monthly medical evaluations, home monitoring and 24-hour profile blood pressure; ambulatory and home monitoring used during intervention period. Steroid profile assessed by LC-MS/MS to guide dose titration."}

Other endpoints

• {"endpoint_text":"- to identify biomarkers of treatment efficacy and monitoring\n- to evaluate the adrenal morphology after treatment with Metyrapone","definition_or_measurement_approach":"Biomarker identification assessed via blood and saliva samples with steroid profile measured by liquid-chromatography tandem mass spectrometry (LC-MS/MS). Adrenal morphology evaluated by abdominal CT scan repeated at end of study."}

Italy

Earliest CTIS Part Ii Submission Date

10-10-2024

Latest Decision Or Authorization Date

20-02-2025

Processing Time Days

133

Number Of Sites

3

Number Of Participants

50

Primary sponsor

Full Name

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Contract research organisations

Name

Clinical Research Technology S.r.l.

Responsibilities

sponsorDuties code: 8

Name

Fullcro S.r.l.

Responsibilities

sponsorDuties codes: 1, 15 (Randomization), 6, 7

Third parties

• {"country":"Italy","full_name":"Fullcro S.r.l.","duties_or_roles":"sponsorDuties codes: 1, 15 (Randomization), 6, 7","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Clinical Research Technology S.r.l.","duties_or_roles":"sponsorDuties code: 8","organisation_type":"Pharmaceutical company"}