Finding Links Between Hot flASHes and CardioVascular Disease

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

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

Conditions2

Interventions1

Locations2 sites

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