Fezolinetant and Vascular Health and Brain Health (NCT07606664) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Fezolinetant and Vascular Health and Brain Health
United States220 participantsStarted 2026-09-25
Plain-language summary
The goal of this clinical trial is to learn whether a study drug called fezolinetant impacts cardiovascular and cognitive health in women who have moderate to severe menopausal hot flashes and night sweats.
Researchers will compare fezolinetant to a placebo. A placebo is a pill that looks like the study drug but does not contain any active medicine. This comparison helps researchers understand whether fezolinetant works better than no treatment.
Participants will:
Be randomly assigned to take either fezolinetant (45 mg) or a placebo once a day for 12 weeks.
Visit the research clinic for regular checkups and tests during the study. Complete tests that measure blood vessel function and cognition.
Participants and study staff will not know which treatment each participant receives during the study.
Who can participate
Age range
40 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Born female
* Age ≥40 - ≤65 years at the time of the screening visit
* Body Mass Index (BMI) ≥18 to ≤38 kg/m2
* Seeking treatment or relief for moderate to severe VMS associated with menopause
* Confirmed menopausal as per one of the following criteria at the time of screening: Reporting spontaneous amenorrhea for ≥12 consecutive months; spontaneous amenorrhea for ≥6 and \< 12 months with follicle-stimulating hormone \>40 IU/L
* Negative urine pregnancy test at screening (if \<12 months of amenorrhea)
* A minimum average of 7-8 moderate to severe VMS per day, or 50-60 per week prior to randomization as reported in the 7-day hot flash diary
* Agrees to not participate in another interventional study (pharmaceutical or device) while participating in this current study
Exclusion Criteria:
* Pregnancy/lactation (past 6 months)
* Any treatment for hot flashes with demonstrated efficacy for hot flashes
* Currently using systemic sex-hormone medications.
* Currently using cytochrome P450 1A2 (CYP1A2) inhibitors (as listed according to the FDA).
* Severely elevated blood pressure \[systolic blood pressure (SBP) \>180 and/or diastolic blood pressure (DBP) \>110\]
* A medical condition or chronic disease (including history of hepatic, renal, cardiovascular, gastrointestinal, pulmonary \[e.g., moderate asthma\], endocrine or gynecological disease) or malignancy that could confound interpretation of the study in the opinion of the investigator or study physician
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Flow-Mediated Dilation
Timeframe: Baseline and end of treatment at 12 weeks.
2
Verbal Memory Performance
Timeframe: Baseline and end of treatment at 12 weeks.