Actively Recruiting
A Real-world Observational Study of Outcomes Among Canadian Women With Bothersome VMS Associated With Menopause Treated With Fezolinetant in Routine Healthcare
Led by Astellas Pharma Europe Ltd. · Updated on 2026-05-22
238
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Canadian women who are in menopause and experiencing bothersome hot flashes and night sweats, also called vasomotor symptoms (VMS). The study focuses on women whose own doctors have prescribed the drug fezolinetant as part of their usual health care. The main goal is to find out if fezolinetant improves these symptoms after 12 weeks, with additional aims to observe benefits over a full year, including better sleep and overall wellbeing. Participants will take oral tablets of fezolinetant every day for up to 52 weeks. This observational study records information about how the drug is used in real-life clinical settings, without the study team deciding on treatment. The study also gathers data on treatment satisfaction, adherence, reasons for starting or stopping the drug, and any safety concerns. Other menopausal treatments taken alongside fezolinetant are tracked as well. Women in the study will provide information through questionnaires and reports at various times during the year, including baseline and weeks 4, 12, 24, and 52. These assessments cover symptom improvement, sleep quality, treatment satisfaction, and side effects. Safety events are monitored up to 56 weeks. All participant data helps researchers understand the effects and use of fezolinetant during routine care, with no extra treatments provided by the study.
CONDITIONS
Brief Title
A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical Practice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant lives in Canada.
- Participant is experiencing vasomotor symptoms (hot flashes and night sweats) associated with menopause.
- Participant is newly prescribed fezolinetant as part of routine clinical care but has not yet started the first dose.
- Participant has acceptable liver function test results within the past 3 months.
- Participant speaks English or French fluently.
- Participant can use and has access to internet-capable digital devices such as a mobile phone or computer.
You will not qualify if you...
- Participant has any contraindications to fezolinetant as described in its label.
- Participant was previously treated with fezolinetant by a physician.
- Participant has a diagnosed sleep disorder not related to menopause symptoms or is taking medication for such sleep disorders.
- Participant is currently or was recently (within 6 months) involved in another interventional clinical study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 56 weeks
Participants who undergo routine care are observed while receiving fezolinetant for menopausal vasomotor symptoms.
Visits at Baseline, Week 4, 12, 24, and 52 with additional safety monitoring up to Week 56
Trial Site Locations
Total: 2 locations
1
Site CA15002
Montreal, Canada
Actively Recruiting
2
Site CA15001
Prince Albert, Canada
Actively Recruiting
Research Team
A
Astellas Pharma Europe Ltd.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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