Finding Links Between Hot flASHes and CardioVascular Disease

Not Applicable

Not yet recruiting

• Conditions: Menopause-related Hot Flashes
• Interventions: Drug: fezolinetant - reference formulation; Drug: placebo

• Registration Number: NCT07077395
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The goal of this clinical trial is to learn if drug fezolinetant improves blood vessel health in women with moderate to severe hot flashes. The main questions it aims to answer are:

Does drug fezolinetant improve blood vessel health?

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Study Start: 2025-10-01
• Primary Completion: 2029-10
• Study Completion: 2030-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

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 1A2 inhibitors
• Elevated liver function tests (ALT, AST, and/or total bilirubin ≥2x ULN)
• Undiagnosed uterine bleeding over past 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fezolinetant 45 mg daily for 12 weeks	fezolinetant - reference formulation	-
Placebo daily for 12 weeks	placebo	-

Primary Outcome Measures

Name	Time	Method
brachial artery flow mediated dilation	12 weeks

Secondary Outcome Measures

Name	Time	Method
eicosanoid metabolites	12 weeks

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States