Finding Links Between Hot flASHes and CardioVascular Disease

Purpose

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?

Condition

  • Menopause-related Hot Flashes

Eligibility

Eligible Ages
Between 40 Years and 65 Years
Eligible Sex
Female
Accepts 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 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
elinzanetant 120 mg daily for 12 weeks
  • Drug: elinzanetant - reference formulation
    elinzanetant 120 mg daily x 12 weeks
Placebo Comparator
Placebo daily for 12 weeks
  • Drug: placebo
    placebo daily x 12 weeks

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Kamila Bielawski
617-643-6161
mghflashcv@mgb.org

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Kamila Bielawski
617-724-3064
mghflashcv@mgb.org