Hot flash drug may unlock heart health secrets in midlife women
NCT ID NCT07077395
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a medication called elinzanetant, which is used for hot flashes, can also improve blood vessel health in women aged 40-65. Participants must have moderate to severe hot flashes and at least two heart risk factors like obesity or high blood pressure. The goal is to see if treating hot flashes can lower the risk of heart disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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