Fezolinetant for Menopausal Hot Flashes and Vascular/Brain Health
This study is investigating whether fezolinetant, a non-hormonal treatment for hot flashes, can improve the health of blood vessels (vascular health) and thinking abilities (brain health) in women experiencing moderate to severe menopausal hot flashes and night sweats. Researchers will compare fezolinetant to a placebo, which looks like the study drug but contains no active medicine. This helps determine if fezolinetant is effective. You may be eligible if you are a woman between 40 and 65 years old, have a BMI between 18 and 38, and are seeking relief for moderate to severe menopausal hot flashes. The study aims to see if fezolinetant improves blood vessel function and verbal memory after 12 weeks of treatment.
- Study design
- This is a double-blind, placebo-controlled randomized trial involving 220 participants. You would be randomly assigned to receive either fezolinetant or a placebo.
- What's involved
- You would take either fezolinetant (45 mg) or a placebo once a day for 12 weeks. You would also have regular checkups and tests, including measurements of blood vessel function and cognition.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your blood vessel function and verbal memory will be measured at the beginning of the study and again at the end of the 12-week treatment period.
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NCT07606664
Fezolinetant and Vascular Health and Brain Health
Not Yet Recruiting
PHASE3Ages 40–65InterventionalTreatmentRebecca ThurstonInvestigator-initiated
~220 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:PlaceboFezolinetant
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Flow-Mediated Dilation
Measured over Baseline and end of treatment at 12 weeks.
+1 more outcome measured
Conditions
Where it's being run
2 sites across 2 statesIllinois1
Pennsylvania1
Study leadership
- Rebecca C Thurston, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Flow-Mediated DilationBaseline and end of treatment at 12 weeks.
Endothelial function assessed by flow-mediated dilation
- Verbal Memory PerformanceBaseline and end of treatment at 12 weeks.
Verbal memory performance on the California Verbal Learning Test