Fezolinetant Experience for the Treatment of Vasomotor Symptoms Associated With Menopause Among Women in a German Real-life Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Percentage of participants reporting improvement in hot flushes/night sweats measured by Patient Global Impression of Change of VMS (PGI-C VMS)
研究概览
简要总结
This study is for women in Germany who are going through menopause. They have symptoms including hot flashes and night sweats (also called vasomotor symptoms). Their doctor has decided to give them fezolinetant tablets to help treat these symptoms. Fezolinetant tablets do not contain hormones. Fezolinetant tablets have been approved in some countries to treat hot flashes and night sweats. Doctors have standard clinical practice guidelines to help them decide how to treat women who are going through menopause and have hot flashes and night sweats. The goal of this study is to learn about the value of fezolinetant tablets in treating hot flashes and night sweats that women in Germany experience during menopause. The women that want to take part in the study will take fezolinetant tablets for their hot flashes and night sweats. This study is about collecting information only. The individual's doctor decides on treatment, not the study sponsor (Astellas). The study will last about 6 months (24 weeks). During the study, the women taking part will complete up to 5 virtual reviews. The virtual reviews will ask the women to complete 3 - 5 surveys. At the first virtual review the women will be asked about their health and other medicines they have taken or are taking. The surveys will ask the women about their hot flashes and night sweats, other menopause symptoms, and how these symptoms affect their health and daily life. After the first or second virtual review the women will take their first dose of fezolinetant tablets and continue taking fezolinetant as explained by their doctor. The women will have 3 virtual follow-up reviews at about 1 week, 3 months (12 weeks), and 6 months (24 weeks) after their first dose of fezolinetant tablets. The women will be asked when they took their fezolinetant tablets or if they stopped taking them.
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 has been prescribed fezolinetant for the treatment of VMS associated with menopause according to routine clinical practice
- •Participant is living in Germany
- •Participant is able to communicate in German language
- •Participant is able to use digital tools and have access to an internet-capable device
排除标准
- •A patient will be excluded if she is participating in clinical trials.
研究组 & 干预措施
Fezolinetant
Participants who are prescribed fezolinetant for the treatment of vasomotor symptoms (VMS) associated with menopause.
干预措施: Fezolinetant (Drug)
结局指标
主要结局
Percentage of participants reporting improvement in hot flushes/night sweats measured by Patient Global Impression of Change of VMS (PGI-C VMS)
时间窗: Week 24
The PGI-C VMS evaluates patient perceived change in hot flashes/night sweats from the initiation of treatment. Ratings range from (1) much better to (7) much worse. A response of "moderately better" or "much better" would be an improvement.
次要结局
- Percentage of participants reporting improvement in hot flushes/night sweats measured by PGI-C VMS(Up to Week 12)
- Change from baseline in VMS in symptom bother measured by the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall Vasomotor domain score(Baseline, Week 12 and Week 24)
- Chage from baseline in menopause-related quality of life (MENQoL) total score(Baseline, Week 12 and Week 24)
- Change from baseline in sleep disturbance measured by Patient Global Impression of Change of Sleep Disturbance (PGI-C SD)(Baseline, Week 1, Week 12 and Week 24)
- Change from baseline in total score of Patient-Reported Outcomes Measurement Information System, Sleep Disturbance - Short Form (PROMIS SD SF) 8b(Baseline, Week 12 and Week 24)
- Treatment satisfaction(Up to Week 24)
- Number of participants who discontinue fezolinetant(Up to Week 24)
- Reasons for discontinuing fezolinetant (including potential switching patterns)(Up to Week 24)
- Number of participants with Adverse Events (AEs)(Up to Week 24)
- Number of participants with Serious Adverse Events (SAEs)(Up to Week 24)