Finding Links Between Hot flASHes and CardioVascular Disease
NCT ID: NCT07077395
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2026-01-31
2030-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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elinzanetant 120 mg daily for 12 weeks
elinzanetant - reference formulation
elinzanetant 120 mg daily x 12 weeks
Placebo daily for 12 weeks
placebo
placebo daily x 12 weeks
Interventions
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elinzanetant - reference formulation
elinzanetant 120 mg daily x 12 weeks
placebo
placebo daily x 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
65 Years
FEMALE
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Emily Lau
Principal Investigator
Principal Investigators
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Emily Lau, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025p001738
Identifier Type: -
Identifier Source: org_study_id
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