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Finding Links Between Hot flASHes and CardioVascular Disease

RecruitingPhase 2Ages 40 Years - 65 YearsFemaleMassachusetts General Hospital
NCT07077395 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improves blood vessel health in women with moderate to severe hot flashes. The main questions it aims to answer is does neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improve blood vessel health?

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 40-65 years * Peri- and post-menopausal women (STRAW -1 to +1) * Moderate or high vasmotor symptom burden * Cardiometabolic disease (as evidenced by ≥ 2 of the following): * Obesity (body mass index ≥ 30 kg/m2) * Elevated waist circumference (≥ 88 cm) * Elevated triglycerides (≥ 150 mg/dL or drug treatment) * Reduced HDL-cholesterol (\<50 mg/dL or drug treatment) * Elevated blood pressure (≥ 130 mmHg systolic blood pressure or ≥ 85 mmHg diastolic blood pressure, or drug treatment) * Elevated fasting glucose (≥ 100 mg/dL or drug treatment) Exclusion Criteria: * Inability to provide informed consent or comply with study protocol * Major comorbidities: cancer, end-stage renal (eGFR \<45 mL/min/1.73 m2), liver or lung disease * Concomitant use of strong or moderate cytochrome P450 3A4 inhibitors * Elevated liver function tests (ALT, AST, and/or total bilirubin ≥2x ULN) * Undiagnosed uterine bleeding over past 6 months
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What it tests

  • elinzanetant - reference formulation
  • placebo
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Where

2 sites
Massachusetts General Hospital
Boston, United States
Brigham and Women's Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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