Finding Links Between Hot flASHes and CardioVascular Disease
FLASH-CV:
1 other identifier
interventional
80
1 country
2
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2026
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2025
CompletedFirst Posted
Study publicly available on registry
July 22, 2025
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
May 20, 2026
May 1, 2026
3.3 years
July 11, 2025
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
brachial artery flow mediated dilation
12 weeks
Secondary Outcomes (1)
concentration of inflammatory protein biomarkers
12 weeks
Study Arms (2)
elinzanetant 120 mg daily for 12 weeks
ACTIVE COMPARATORPlacebo daily for 12 weeks
PLACEBO COMPARATORInterventions
elinzanetant 120 mg daily x 12 weeks
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily Lau, MD, MPH
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 11, 2025
First Posted
July 22, 2025
Study Start
March 1, 2026
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
September 1, 2029
Last Updated
May 20, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL