Menopause-related Hot FlashesPhase 2FLASH-CV:NCT07077395
Finding Links Between Hot flASHes and CardioVascular Disease
A Phase 2 study testing elinzanetant - reference formulation in people with Menopause-related Hot Flashes, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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? Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopause-related Hot Flashes
- What is being tested?
- elinzanetant - reference formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2026to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kamila Bielawski, 617-724-3064, mghflashcv@mgb.org
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Kamila Bielawski, 617-643-6161, mghflashcv@mgb.org
About this study
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?
- Conditions
- Menopause-related Hot Flashes
- Being tested
- elinzanetant - reference formulation, placebo
- Keywords
- menopause, hot flashes, heart health
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elinzanetant - reference formulationDrug
elinzanetant 120 mg daily x 12 weeks
placeboDrug
placebo daily x 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| elinzanetant 120 mg daily for 12 weeks | Active comparator | Not described Receives: Drug: elinzanetant - reference formulation |
| Placebo daily for 12 weeks | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
brachial artery flow mediated dilation
Measured: 12 weeks
Secondary outcomes (1)
concentration of inflammatory protein biomarkers
- General inflammatory markers: hsCRP, IL-8, TNF-ɑ/β
- Leukocyte adhesion markers: MCP-1, ICAM-1
- Markers of vascular homeostasis: ANGPT1, VEGFA, HB-EGF
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Mar 2026
- Primary completionJun 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause-related Hot FlashesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Lau, Massachusetts General Hospital
- Investigators
- Emily Lau, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077395
- Sponsor's protocol ID
- 2025p001738
- Acronym
- FLASH-CV:
- Status last verified
- May 2026
- First submitted
- 11 Jul 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding Links Between Hot flASHes and CardioVascular Disease
- ClinicalTrials.gov ID
- NCT07077395
- Acronym / sponsor ID
- FLASH-CV: / 2025p001738
- Conditions
- Menopause-related Hot Flashes
- Keywords
- menopause, hot flashes, heart health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elinzanetant 120 mg daily for 12 weeks | Active comparator | Drug: elinzanetant - reference formulation |
| Placebo daily for 12 weeks | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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):
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elinzanetant - reference formulationelinzanetant 120 mg daily x 12 weeks | Drug | elinzanetant 120 mg daily for 12 weeks |
| placeboplacebo daily x 12 weeks | Drug | Placebo daily for 12 weeks |
Primary outcome
brachial artery flow mediated dilation
Time frame: 12 weeks
1 secondary outcome
concentration of inflammatory protein biomarkers
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Lau, MD, MPH principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing elinzanetant - reference formulation in people with Menopause-related Hot Flashes, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kamila Bielawski (617-724-3064, mghflashcv@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brachial artery flow mediated dilation (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.