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Fezolinetant and Vascular Health and Brain Health

NCT07606664 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-05-26

No results posted yet for this study

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.

Conditions

  • Menopause Hot Flashes

Interventions

DRUG

Placebo

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).

DRUG

Fezolinetant

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.

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    collaborator INDUSTRY

  • Rebecca Thurston

    lead OTHER

Principal Investigators

  • Rebecca C Thurston, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-25
Primary Completion
2029-11-30
Completion
2029-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07606664 on ClinicalTrials.gov