RecruitingOBSERVATIONAL

A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical Practice

This study is for women in Canada who are going through menopause and having hot flashes and night sweats. Their own doctor has already decided to prescribe them a new medicine called fezolinetant. This study isn't about testing a new drug, but rather about carefully watching how fezolinetant helps these women when used in real-life medical practice. Researchers want to see if it improves hot flashes and night sweats after 12 weeks, and throughout the year-long study. They will also look at how it affects sleep, general wellbeing, and how happy women are with the treatment. The study also records any side effects and why some women might stop taking the medicine. This helps doctors understand how well fezolinetant works for women in general care.

At a glance

Status

Recruiting

Sponsor

Astellas Pharma Europe Ltd.

Enrolment target

238

Start

23 Oct 2025

Estimated completion

30 Nov 2027

Hot Flashes

What is this study about?

This study is for women in Canada who are experiencing menopause and having common symptoms like hot flashes and night sweats. These symptoms can be really bothersome and affect daily life and sleep. The study is especially for women whose doctors have decided to prescribe them a new medicine called fezolinetant as part of their regular care. It's important to know that the decision to give fezolinetant is made by your own doctor, not by the study organizers or the company making the medicine. The study simply observes how the medicine works when used in everyday healthcare.

The main goal of this study is to understand if fezolinetant helps reduce hot flashes and night sweats within 12 weeks of starting the treatment. But it doesn't stop there. Researchers also want to see if these improvements continue over the whole year that women take the medicine. They'll also be looking at other important things, like how well women sleep, how it affects their overall mood and wellbeing, and how satisfied they are with the treatment. This helps create a complete picture of how fezolinetant impacts women's lives.

Throughout the study, information will be collected about any other medicines women are taking, any side effects they experience, and if they stop taking fezolinetant, what the reasons were. This detailed information is really valuable because it helps doctors and researchers learn more about how fezolinetant works in a real-world setting. It contributes to our understanding of how this new treatment can best help women manage their menopause symptoms.

Key takeaways

This study observes fezolinetant for menopause symptoms in real-world use.
It's for Canadian women already prescribed fezolinetant by their own doctor.
The study tracks improvements in hot flashes, sleep, and wellbeing for up to one year.
You record your experiences, usually using a digital device.
Taking part helps doctors understand how fezolinetant works for many women.
Your decision to join is voluntary and won't affect your medical care.

Who may be eligible?

This study is for women who live in Canada and are experiencing hot flashes and night sweats due to menopause. You would be considered if your doctor has recently decided to prescribe you fezolinetant, and you haven't started taking the medicine yet. Your doctor must have made this decision before you even think about joining the study. You'll also need to have had a recent liver function test with good results, as this is important for taking fezolinetant. You should be able to speak either English or French fluently, and be comfortable using a mobile device or computer with internet access.

You wouldn't be able to join if you have any health conditions that your doctor knows would make fezolinetant unsafe for you. If you've taken fezolinetant before, or if you have a sleep disorder like insomnia that isn't caused by your hot flashes and night sweats, you might not be eligible. This study is also not for those currently taking part in another medical study or who have been in another study in the last six months where you received a treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I live in Canada.
I am experiencing hot flashes and night sweats due to menopause.
My doctor has recently prescribed fezolinetant, and I haven't started taking it yet.
I have had a recent liver function test with good results.
I can speak English or French and use a digital device with internet.
I haven't taken fezolinetant before and am not in another medical study for a treatment.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be taking fezolinetant tablets daily, exactly as your own doctor prescribed. This study is purely about observing and recording information; you won't be given any experimental treatment or different doses than what your doctor decided. You'll be asked to provide information about your hot flashes, night sweats, sleep, and general wellbeing regularly. This will likely involve using a digital device, like a mobile phone or computer, to record your experiences and answer questions.

The study will follow you for up to 52 weeks, which is about one year, while you continue to take fezolinetant. There are no extra doctor visits required specifically for the study, beyond your usual appointments with your own healthcare provider. Any information about other medications you take, reasons for stopping fezolinetant, and any side effects will also be recorded.

Potential risks and benefits

The potential benefit of taking part in this study is contributing to important medical knowledge about how fezolinetant helps women manage hot flashes and night sweats in routine care. This can help other women in the future. As you are already being prescribed fezolinetant by your doctor, you would be taking the medicine anyway, so any potential side effects relate to the medicine itself rather than the study. The study will carefully record any safety concerns. You can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Site CA15002
Verified postcode
Montreal, Canada· Recruiting
Site CA15001
Verified postcode
Prince Albert, Canada· Recruiting

Common questions

What is fezolinetant?

Fezolinetant is a new medicine prescribed to help women reduce hot flashes and night sweats during menopause.

Do I have to take part in the study if my doctor prescribes fezolinetant?

No, taking part is completely your choice. Your doctor's decision to prescribe fezolinetant is separate from the study.

Will I get free medicine if I join this study?

No, the study doesn't provide the medicine. You would continue to get fezolinetant through your usual healthcare provider, just as your doctor prescribed it.

What kind of information will I need to share?

You'll be asked about your hot flashes, night sweats, sleep, how you're feeling overall, and your satisfaction with the medicine. This will usually be done using a digital device.

What happens if I decide to stop taking fezolinetant?

If you and your doctor decide to stop the medicine, this will be recorded by the study, along with the reasons why. You can also leave the study at any time.

How to find out more

Astellas Pharma Europe Ltd.

astellas.registration@astellas.com +1-800-888-7704 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.