一项观察性研究，旨在进一步了解Elinzanetant在美国有更年期症状女性中的使用情况及其疗效 (RELIEF)
RELIEF：关于ELInzanEtant治疗绝经后女性血管舒缩症状的真实世界证据
Menopause is a natural stage in a woman's life happening between ages 45 and 55. It is often associated with disruptive symptoms like hot flashes and sleep disturbances that can affect up to 8 out of 10 women and make daily life harder. Elinzanetant is a new, hormone free medicine that works by blocking certain signals in the brain that are linked to these symptoms. It has already been shown in clinical studies to help reduce hot flashes. This study is being done to learn about how elinzanetant is used, how well it works, and how safe it is for women with menopause symptoms in real-world, everyday medical care. The main goal is to understand who is starting treatment with elinzanetant and what symptoms they have. The study will also look at how well elinzanetant helps with hot flashes, night sweats, and sleep problems, how safe it is, how satisfied women are with the treatment, and how it affects their quality of life and daily activities. To do this, researchers will follow about 1,500 women in the United States who are starting elinzanetant as part of their usual care. Women will answer questions about their symptoms, sleep, and daily life using a secure app on their phone or computer. Some women will also wear a smart ring for a few weeks to collect information about their sleep. The study will last about 12 weeks for most women, but some will be followed for up to 2 years. No extra treatments or tests will be given as part of the study-researchers will only collect information about how women are doing while taking elinzanetant as prescribed by their own doctor. The results will help doctors and patients understand how elinzanetant works in real life and support better care for women going through menopause.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Bayer Clinical Trials Contact
- 电话号码：18888422937
- 邮箱：clinical-trials-contact@bayer.com
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Women in the US who are newly initiating treatment with elizanetant
描述
Inclusion Criteria:
- Women who newly initiate elinzanetant for treatment of menopausal VMS according to the current local label.
- Signed ICF.
- Ability and willingness to use study-related digital tools and to complete electronic questionnaires (ePROs), requiring access to an internet-connected device.
Exclusion Criteria:
• Participation in an investigational trial with interventions outside of routine clinical practice.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Group 1
Elizanetant users |
The study is observational and does not mandate any specific diagnostic or monitoring procedures beyond standard of care |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
社会人口统计学特征
大体时间：第 1 天
|
第 1 天
|
|
|
绝经开始后时间及绝经症状出现后时间
大体时间：第 1 天
|
第 1 天
|
|
|
对既往血管舒缩症状（VMS）相关临床史的描述性分析
大体时间：第一天
|
第一天
|
|
|
身高
大体时间：第1天、第4周和第12周
|
第1天、第4周和第12周
|
|
|
体重
大体时间：第1天、第4周和第12周
|
第1天、第4周和第12周
|
|
|
Menopausal status
大体时间：Day 1
|
Perimenopausal, natural postmenopaulsa, surgical-induced menopuase, early/premature menopause. |
Day 1
|
|
Menopausal symptoms measured by MENQOL
大体时间：Day 1, week 4,12 and when applicable at week 24, 52, 104
|
MENQOL: Menopause-Specific Quality of Life Questionnaire. It contains 29 items questionnaire that assess presence of menopausal symptoms and how bothersome they are, across four domains: vasomotor, psychosocial, physical and sexual. For each item, the participant indicates if they have experienced the symptom (yes/no). If participants select yes, participants rate how bothered they were by the symptom using a scale with response options ranging from 0 'not at all bothered' to 6 'extremely bothered'. Based on the individual responses, item scores, domain scores, and a total MENQOL score are calculated. Each score ranges from 1-8, higher scores indicate greater bother. |
Day 1, week 4,12 and when applicable at week 24, 52, 104
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
严重不良事件和严重治疗期不良事件数量
大体时间：从第1天到第12周或适用时到第104周
|
从第1天到第12周或适用时到第104周
|
|
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启动、停用或转换elizanetant的原因
大体时间：第4周、第12周以及适用时第52周
|
第4周、第12周以及适用时第52周
|
|
|
elizanetant 的处方量
大体时间：第4周、第12周以及适用时第52周
|
第4周、第12周以及适用时第52周
|
|
|
漏服剂量次数
大体时间：第4周、第12周以及适用时第52周
|
第4周、第12周以及适用时第52周
|
|
|
漏服剂量原因
大体时间：第4周、第12周以及适用时第52周
|
第4周、第12周以及适用时第52周
|
|
|
Change in VMS from the baseline period to week 4 and 12
大体时间：Week 4 and 12
|
Baseline period: Time prior to first dose of elizanetant |
Week 4 and 12
|
|
Change in sleep disturbances measured by PROMIS-SD-SF-8b questionnaire
大体时间：Week 4, 12 and when applicable week 24, 52 and 104
|
PROMIS-SD-SF-8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b. It includes 8 items that assess self-reported sleep quality and sleep difficulties. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Four of the items are scored reversely. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance. |
Week 4, 12 and when applicable week 24, 52 and 104
|
|
HCP reasons for prescribing elinzanetant
大体时间：Day 1
|
HCP: Health care professionals. |
Day 1
|
|
Participants' satisfaction with treatment for symptoms associated with menopause
大体时间：Week 12 and week 52 when applicable
|
Measured by Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ). The MS-TSQ comprises 8 items and assesses satisfaction over the past four weeks to evaluate treatment satisfaction related to menopausal symptoms. Items are scored 1-5 on a Likert scale where 1 = very dissatisfied/not at all and 5 = very satisfied/very much |
Week 12 and week 52 when applicable
|
|
Change in menopauase-related QoL
大体时间：Day 1 to week 4, 12 and when applicable week 24, 52 and 104
|
Measured by Menopause-Specific Quality of Life Questionnaire (MENQOL) |
Day 1 to week 4, 12 and when applicable week 24, 52 and 104
|
|
Change in participant's affect
大体时间：From week 1 to week 4, 12 and when applicable to week 24, 52 and 104
|
Measured by Positive and Negative Affect Schedule - Short Form (PANAS-SF). PANAS-SF Comprises 10 items evaluating how frequently individuals experience positive and negative affect. Items are scored in a 1-5 Likert scale where 1 = Very slightly or not at all and 5 = Extremely. |
From week 1 to week 4, 12 and when applicable to week 24, 52 and 104
|
|
Change in work productivity and daily activity impairment
大体时间：From day 1 to week 4, 12 and when applicable to week 24, 52 and 104
|
Measured by menopause-related Work Productivity and Activity Impairment (WPAI: Menopause). WPAI: Menopuase consists of 6 items assessing employment status, work hours, absenteeism, presenteeism (on-the-job productivity), and the impact of menopausal symptoms on both work and nonwork daily activities. Items are scored as yes/no or ranked from 0 "no effect" to 10 "completely affected". |
From day 1 to week 4, 12 and when applicable to week 24, 52 and 104
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 22958
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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