Menopause Clinical Trials

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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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Site CA15002
RECRUITING
Montreal
Site CA15001
RECRUITING
Prince Albert
Contact Information
Primary
Astellas Pharma Europe Ltd.
astellas.registration@astellas.com
+1-800-888-7704
Time Frame
Start Date: 2025-10-23
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 238
Treatments
Fezolinetant
Participants who have been prescribed fezolinetant as part of routine clinical care for the treatment of bothersome VMS associated with menopause.
Related Therapeutic Areas
Sponsors
Leads: Astellas Pharma Europe Ltd.

This content was sourced from clinicaltrials.gov