Metyrapone Study for Patients Diagnosed With Mild Autonomous Cortisol Secretion - MACS
A legfontosabb adatok
- Hol
- Rochester (Egyesült Államok)A helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Mayo ClinicRochester, Egyesült ÁllamokContact: Vanessa Fell, MARésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Mayo Clinic
- Azonosító
- NCT07138274
- A regiszteradat frissítve
- 2026. szeptember 25.
- Eredeti leírás
single-center, randomized, double-blind, placebo-controlled Phase 2 study to evaluate safety and efficacy of overnight metyrapone in patients with MACS.A teljes eredeti leírásKevesebb
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Metyrapone in Subjects Diagnosed With Mild Autonomous Cortisol Secretion (MACS)
single-center, randomized, double-blind, placebo-controlled Phase 2 study to evaluate safety and efficacy of overnight metyrapone in patients with MACS.
Bevonási feltételek: Provide written informed consent; Stated willingness to comply with all study procedures and availability for the duration of the study; Age ≥ 18 years; Diagnosed with MACS i. at least 2 abnormal post-dexamethasone cortisol results1 mg post-dexamethasone cortisol >1.8 mcg/dL or ii. 8 mg post-dexamethasone cortisol >1 mcg/dL b. Historical dexamethasone suppression test results can be used if performed within 24 months prior to enrollment; Adrenal imaging phenotype consistent with benign disease (adrenal adenoma/s, macronodular or micronodular adrenal hyperplasia); At least one of the following comorbidities:; obesity (BMI>30 kg/m2); dysglycemia; dyslipidemia; hypertension; osteopenia; osteoporosis; fragility fractures; Ability to take oral medication and be willing to adhere to the study intervention regimen; For persons of childbearing potential: : agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of ≤ 5% per year during the treatment period and for 1 month after the last dose of study treatment; Stable timing for bedtime for at least one week prior to on-site study visits; History of difficulty providing blood via standard blood draw methods.
Kizáró feltételek: Planned alternative therapy for MACS within 12 months after joining the study; Current use of oral exogenous glucocorticoid therapy; Current use of opioid therapy >20 MME/day; Planned use of oral exogenous glucocorticoid therapy; Planned use of opioid therapy >20 MME/day; Use of injectable glucocorticoid within 6 weeks prior to Day 1; Investigator's judgement based on history/physical examination that a comorbidity or concomitant medication may impact the hypothalamic-pituitary-adrenal axis or steroid metabolome; Suspected false positive post-dexamethasone cortisol results due to increased metabolism, poor absorption, or noncompliance with dexamethasone; Treatment with another investigational drug or other intervention within lower than specific therapy washout period; Uncontrolled intercurrent illness including, but not limited to:; Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia; Psychiatric illness/social situations that would limit compliance with study requirements; Known allergic reactions to metyrapone; Pregnancy or lactation.