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RECRUITING
NCT07602530

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

Sponsor: Astellas Pharma Europe Ltd.

View on ClinicalTrials.gov

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.

Official title: A Real-world Observational Study of Outcomes Among Canadian Women With Bothersome VMS Associated With Menopause Who Are Treated With Fezolinetant in a Real-life Setting According to Routine Healthcare Practice

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

238

Start Date

2025-10-23

Completion Date

2027-11-30

Last Updated

2026-05-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Fezolinetant

Oral

Locations (2)

Site CA15002

Montreal, Canada

Site CA15001

Prince Albert, Canada