NCT07077395 · Massachusetts General Hospital
Finding Links Between Hot flASHes and CardioVascular Disease
(FLASH-CV:)
What this study is about
The goal of this clinical trial is to learn if drug fezolinetant improves blood vessel health in women with moderate to severe hot flashes.
View original scientific description
The goal of this clinical trial is to learn if drug fezolinetant improves blood vessel health in women with moderate to severe hot flashes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2026 · Source of record for eligibility and locations