RELIEF: Real World Evidence on ELInzanEtant For the Treatment of Vasomotor Symptoms in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Socio-demographic characteristics
研究概览
简要总结
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
- •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.
排除标准
- •Participation in an investigational trial with interventions outside of routine clinical practice.
研究组 & 干预措施
Group 1
Elizanetant users
干预措施: No intervention (Other)
结局指标
主要结局
Socio-demographic characteristics
时间窗: Day 1
Menopausal status
时间窗: Day 1
Perimenopausal, natural postmenopaulsa, surgical-induced menopuase, early/premature menopause.
Time since menopause onset and time since onset of menopausal symptoms
时间窗: Day 1
Descriptive analyses of prior vasomotor symptoms (VMS) related clinical history
时间窗: Day 1
Menopausal symptoms measured by MENQOL
时间窗: 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.
Height
时间窗: Day 1, week 4 and week 12
Weight
时间窗: Day 1, week 4 and week 12
次要结局
- HCP reasons for prescribing elinzanetant(Day 1)
- Change in VMS from the baseline period to week 4 and 12(Week 4 and 12)
- Change in sleep disturbances measured by PROMIS-SD-SF-8b questionnaire(Week 4, 12 and when applicable week 24, 52 and 104)
- Number of SAE and serious TEAE(From Day 1 to week 12 or week 104 when applicable)
- Participants' satisfaction with treatment for symptoms associated with menopause(Week 12 and week 52 when applicable)
- Reasons for initiation, discontinuation or switching of elizanetant(Week 4, week 12 and when applicable week 52)
- Amount of elizanetant prescribed(Week 4, week 12 and when applicable week 52)
- Number of missed doses(Week 4, week 12 and when applicable week 52)
- Reasons for missed doses(Week 4, week 12 and when applicable week 52)
- Change in menopauase-related QoL(Day 1 to week 4, 12 and when applicable week 24, 52 and 104)
- Change in participant's affect(From week 1 to week 4, 12 and when applicable to week 24, 52 and 104)
- Change in work productivity and daily activity impairment(From day 1 to week 4, 12 and when applicable to week 24, 52 and 104)