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Could a hot flash drug also protect your heart and memory?

NCT ID NCT07606664

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether fezolinetant, a drug for menopausal hot flashes and night sweats, also improves blood vessel function and memory. About 220 women aged 40–65 with moderate to severe symptoms will take either fezolinetant or a placebo daily for 12 weeks. Researchers will measure changes in artery health and cognitive performance to see if the drug offers benefits beyond symptom relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fezolinetant
What this could lead to
If it works, this could show that fezolinetant not only eases hot flashes but also protects blood vessels and memory during menopause.
What could go wrong
This is a Phase 3 trial, but it's still early to know if fezolinetant improves heart or brain health. The study is small and results may not apply to all women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

40 to 65 years

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * Self-reported narcolepsy * Previous/current history of a malignant tumor, except for basal cell carcinoma * Participants with known cirrhosis, active liver disease, jaundice, or elevated liver aminotransferases or total bilirubin (ALT, AST, and total bilirubin), should not be enrolled if ALT or AST is ≥ 2 x ULN or if the total bilirubin is ≥ 2 x ULN for the evaluating laboratory. Participants with ALP \> 1.5 × ULN and judged clinically significant by the study physician. * Severe renal impairment \[estimated glomerular filtration rate (eGFR) 15 to \<30 mL/min per 1.73 m2\] or end-stage renal disease (ESRD) (eGFR \< 15 mL/min/1.73 m2) at screening as per USPI * Positive Hepatitis C virus antibody, Hepatitis B surface antigen, and/or human immunodeficiency virus antibody screen at screening * History within the last 6 months of undiagnosed uterine bleeding * Key medical conditions (history of cardiovascular disease, stroke/cerebrovascular accident, brain injury with loss of consciousness for more than 60 seconds within the last five years, cognitive disorders, brain tumor, dementia, Parkinson's disease, chemotherapy, psychotic disorders) * Metal in the body, claustrophobia, or cannot undergo 3T magnetic resonance imaging (MRI); Inability to meet MRI eligibility criteria * Lymph node removal on both sides of the body, mastectomy, or dialysis * Hysterectomy; levonorgestrel-releasing intrauterine systems initiated before 12 months of spontaneous amenorrhea (Not exclusionary if placed after 12 months of spontaneous amenorrhea), or history of endometrial ablation will be excluded due to inability to stage menopause; Bilateral oophorectomy if completed prior to 12 months of spontaneous amenorrhea * Cardiovascular medication use. * Prior exposure to fezolinetant or elinzanetant * Current participation in another interventional study or participated in an interventional study or received any investigational drug within 3 months * Illicit substance use reported in the past week or detected by urine toxicology screen. * Subject has any condition, which in the investigator's or study physician's opinion, makes the subject unsuitable for study participation.

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Conditions

The condition(s) this trial relates to.

Hot Flashes

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University of Illinois, Chicago

    Chicago, Illinois, 60612, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.