Menopause-related Hot Flashes
Conditions
Keywords
menopause, hot flashes, heart health
Brief 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?
Interventions
DRUGelinzanetant - reference formulation
elinzanetant 120 mg daily x 12 weeks
DRUGplacebo
placebo daily x 12 weeks
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| brachial artery flow mediated dilation | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| concentration of inflammatory protein biomarkers | 12 weeks | * General inflammatory markers: hsCRP, IL-8, TNF-ɑ/β * Leukocyte adhesion markers: MCP-1, ICAM-1 * Markers of vascular homeostasis: ANGPT1, VEGFA, HB-EGF |
Countries
United States
Contacts
CONTACTKamila Bielawski
PRINCIPAL_INVESTIGATOREmily Lau, MD, MPH
Massachusetts General Hospital
Outcome results
None listed