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

Astellas

Status

Enrolling

Conditions

Hot Flashes

Treatments

Drug: Fezolinetant

Study type

Observational

Funder types

Industry

Identifiers

NCT07602530

2693-MA-3603

Details and patient eligibility

About

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.

Enrollment

238 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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.