Menopause Hot FlashesPhase 3FAVES-BNCT07606664
Fezolinetant and Vascular Health and Brain Health
A Phase 3 study testing Fezolinetant in people with Menopause Hot Flashes, run by Rebecca Thurston at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopause Hot Flashes
- What is being tested?
- Fezolinetant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Sep 2026to 30 Dec 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Illinois, Chicago
Chicago, Illinois, 60612
Ece K Weishaar, MS, 312-996-1623, EceKilic@UIC.Edu
Pauline M Maki, PhD
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Sarah M Conklin, PhD, 8782616899, conklinsm2@upmc.edu
Mollie B Bandy, BA, 8782616899, BANDYMB@upmc.edu
About this study
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.
Read more
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.
Read the detailed description
Double-blind, placebo-controlled randomized trial to determine whether 12 weeks of 45 mg of fezolinetant, a non-hormonal treatment for hot flashes associated with menopause, improves vascular and brain health in participants with moderate to severe menopausal hot flashes. Participants will be randomized to either 12 weeks of fezolinetant 45 mg or placebo. Primary endpoints include change from baseline in endothelial function and verbal memory.
- Conditions
- Menopause Hot Flashes
- Being tested
- Placebo, Fezolinetant
- Keywords
- menopause, hot flashes, vascular health, brain health, women's health, cognition
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
The placebo tablet will be an identical tablet appearing to active medication. The placebo tablets contain the following inactive ingredients: ferric oxide, hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide).
FezolinetantDrug
Fezolinetant is a white powder. It is very slightly soluble in water (0.29 mg/mL). Fezolinetant tablets that will be used in this study are round, light red film-coated tablets with no marking on the tablets. Each fezolinetant tablet for oral use contains 45 mg of fezolinetant and the following inactive ingredients: ferric oxide, hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | The placebo tablet will be an identical tablet appearing to active medication. The placebo tablets contain the following inactive ingredients: ferric oxide, hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Receives: Drug: Placebo |
| Active Study Drug | Experimental | Fezolinetant is a white powder. It is very slightly soluble in water (0.29 mg/mL). Fezolinetant tablets that will be used in this study are round, light red film-coated tablets with no marking on the tablets. Each fezolinetant tablet for oral use contains 45 mg of fezolinetant and the following inactive ingredients: ferric oxide, hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Receives: Drug: Fezolinetant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-Mediated Dilation
Endothelial function assessed by flow-mediated dilation
Measured: Baseline and end of treatment at 12 weeks.
Verbal Memory Performance
Verbal memory performance on the California Verbal Learning Test
Measured: Baseline and end of treatment at 12 weeks.
Secondary outcomes (6)
Endothelial Biomarkers
Blood-based endothelial function biomarkers
Measured: Baseline and end of treatment at 12 weeks.
Brain Activation during Verbal Encoding
Memory circuitry as measured by changes in brain activation during performance of a functional magnetic resonance imaging (fMRI) task of verbal encoding
Measured: Baseline and end of treatment at 12 weeks.
Functional Connectivity during recall
Memory circuitry as measured by changes in functional connectivity during performance of a functional magnetic resonance imaging (fMRI) task of verbal recall
Measured: Baseline and end of treatment at 12 weeks.
Subjective Vasomotor Hot Flash Diary
frequency of subjectively assessed VMS using a digital hot flash diary
Measured: Baseline and end of treatment at 12 weeks.
Objective Vasomotor Monitoring
Frequency of objectively measured VMS using 24-hour skin conductance monitoring
Measured: Baseline and end of treatment at 12 weeks.
Sleep Monitoring
Objective sleep monitoring.
Measured: Baseline and end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start25 Sep 2026 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rebecca Thurston
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Global Development, Inc.
- Responsible party
- Sponsor-investigator, Rebecca Thurston, University of Pittsburgh
- Investigators
- Rebecca C Thurston, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606664
- Sponsor's protocol ID
- STUDY25120039
- Acronym
- FAVES-B
- Status last verified
- Aug 2026
- First submitted
- 18 May 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No