A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flas… (NCT07602530) | Clinical Trial Compass
RecruitingNot Applicable
A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical Practice
Canada238 participantsStarted 2025-10-23
Plain-language summary
This study is for women in Canada who are in menopause. They have symptoms including hot flashes and night sweats (also known as vasomotor symptoms or VMS). Their own doctor has prescribed fezolinetant for hot flashes and night sweats, as part of routine health care in Canada.
In this study, women will be taking tablets of fezolinetant. This study is about recording information only. The women's own doctor decides on treatment, not the study sponsor (Astellas).
Women are taking fezolinetant every day for up to 52 weeks (1 year). The main aim is to learn if fezolinetant improves hot flashes and night sweats after 12 weeks. Other aims are to learn if fezolinetant improves hot flashes and night sweats throughout the study. This includes improved sleep and the women's wellbeing. Details are recorded on how satisfied the women are with fezolinetant and if they completed their treatment. This includes reasons for stopping treatment. Any safety issues are recorded. Details about other treatments taken before or with fezolinetant are also recorded.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants reporting improvement in hot flashes/night sweats: Patient Global Impression of Change (PGI-C) VMS