New drug fezolinetant tested for hot flash relief in everyday life

NCT ID NCT07602530

Symptom relief Sponsor: Astellas Pharma Europe Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows Canadian women in menopause who are prescribed fezolinetant by their own doctors for hot flashes and night sweats. Over 1 year, researchers track how well the drug improves symptoms, sleep, and well-being, as well as any side effects. It's a real-world look at how the treatment works outside of a controlled lab setting.

What this could mean

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

Active substance: fezolinetant (VEOZAH)
What this could lead to: If successful, this study could confirm that fezolinetant effectively reduces hot flashes and night sweats in real-world settings, improving sleep and quality of life for menopausal women.
What could go wrong: This is an observational study, not a controlled trial, so results may be less reliable. It only includes Canadian women, and outcomes depend on patient reports, which can vary.

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.

Participants

About 238 people

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

Started

Oct 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants who have been prescribed fezolinetant as part of routine clinical care for the treatment of bothersome VMS associated with menopause.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Participant lives in Canada. * Participant is experiencing VMS associated with menopause. * Participant is newly prescribed fezolinetant as part of routine clinical care but has not yet initiated the first dose. The decision to prescribe fezolinetant must be made prior to and independent of study participation. * Participant has acceptable hepatic function test results within the past 3 months prior to taking the first dose as described in the fezolinetant label. * Participant is a fluent speaker of English or French. * Participant is able to use digital devices and has access to an internet-capable device such as a mobile device or computer. Exclusion Criteria: * A participant will be excluded if they have contraindications as described in the fezolinetant label. * A participant will be excluded if they were previously treated with fezolinetant by a physician. * A participant will be excluded if they have been clinically diagnosed with a sleep disorder (e.g., insomnia, narcolepsy) and/or is taking medication to improve a sleep disorder not associated with VMS (i.e., a participant with sleep disturbance associated with VMS is eligible). * A participant will be excluded if they are currently participating in an interventional study or previously participated in another interventional study within 6 months of the first dose of fezolinetant.

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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.

Hot flashes

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

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

New drug fezolinetant tested for hot flash relief in everyday life

What the study statuses mean