Finding Links Between Hot flASHes and CardioVascular Disease
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Menopause-related Hot Flashes
In brief
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?
Key facts
- Study ID
- NCT07077395
- Run by
- Massachusetts General Hospital
- People needed
- 80
- Starts
- 2026-03-01
- Expected to finish
- 2029-09-01
- Last updated by the study team
- 2026-05-20
Who can join
Age: 40 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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