Fezolinetant and Vascular Health and Brain Health

Conditions

• Menopause Hot Flashes

Eligibility Criteria

Sex

FEMALE

Age

40 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  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).
• Fezolinetant — DRUG
  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 Details

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.

Key Dates

Start date

Sep 25, 2026

Status verified

Apr 2026

Primary completion

Nov 30, 2029

Completion

Dec 30, 2029

Study Design

Enrollment

220 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo Arm
  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.
• Experimental: Active Study Drug
  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.

Primary Outcome Measure

Flow-Mediated Dilation [ Time Frame: Baseline and end of treatment at 12 weeks. ]

Central Contacts

• Sarah M Conklin, PhD
  878-261-6899
  [email protected]
• Mollie B Bandy, BA
  412-648-9088
  [email protected]

Locations (2)

Find similar trials in Chicago, IL

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