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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 238
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.