Finding Links Between Hot flASHes and CardioVascular Disease
Massachusetts General Hospital
Summary
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?
Eligibility
- Age range
- 40–65 years
- Sex
- Female
- Healthy volunteers
- No
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 Crit…
Interventions
- Drugelinzanetant - reference formulation
elinzanetant 120 mg daily x 12 weeks
- Drugplacebo
placebo daily x 12 weeks
Locations (2)
- Massachusetts General HospitalBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts