Fezolinetant use for menopausal hot flashes in Canada

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study collects real-world data from women in Canada who are prescribed fezolinetant for hot flashes and night sweats. Participants take fezolinetant daily for up to 52 weeks, and researchers record outcomes on hot flashes, sleep, well-being, treatment satisfaction, and safety. The study focuses on whether fezolinetant improves vasomotor symptoms at 12 weeks and throughout the follow-up, based on routine clinical care rather than a randomized design. Data come from the treating physicians and patient reports, with no experimental assignment by the sponsor. Eligibility requires current prescription, English or French fluency, and access to an internet-enabled device.

Why it matters

Who can join: the full rules

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.

Where it's running

• Site CA15002
  Montreal, Canada Recruiting
• Site CA15001
  Prince Albert, Canada Recruiting

Study contacts

• Study coordinator: Astellas Pharma Europe Ltd.
• Email: astellas.registration@astellas.com
• Phone: +1-800-888-7704

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.