Prospective Survey of Women With Vasomotor Symptoms Associated With Menopause in Nordic Europe, Canada, Brazil and Mexico - WARM Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,176
- 试验地点
- 1
- 主要终点
- Prevalence of moderate to severe vasomotor symptoms (VMS) in post-menopausal women
研究概览
简要总结
This study is an online survey of women in and around menopause with moderate to severe hot flashes. Menopause, a normal part of life, is a time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life.
This study is about collecting information only. There will be no treatment in this study.
This study will provide information about how many women have moderate to severe hot flashes in menopause. It will also provide details on women's experiences with hot flashes.
Women from Brazil, Canada, Nordic Europe, and Mexico will take part in this study. The women in this study will already be taking part in consumer panels. Women will be contacted based on their age. They will be asked if they would like to take part in this study.
Firstly, the women will answer questions about whether they are in menopause or are getting close to menopause. They will also be asked how severe their hot flashes are.
From their answers, some women will be asked to complete an online survey. These will be women who are in menopause and have moderate to severe hot flashes. They will provide more details about how hot flashes have impacted their lives. Also, they will answer questions on how hot flashes affect their quality of life. Finally, they will answer questions about their experiences when they visited their doctor about their hot flashes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Prevalence of moderate to severe vasomotor symptoms (VMS) in post-menopausal women
时间窗: 1 day (once through survey)
Prevalence of moderate to severe VMS in post-menopausal women. Post-menopause is defined as at least 12 consecutive months without a period. Moderate VMS associated with menopause symptoms is defined as sensations of heat with sweating but being able to continue activities. Severe VMS associated with menopause is defined as feelings of intense heat with sweating causing cessation of activities. The recall period is 1 month prior to survey.
次要结局
- Health Related Quality of Life (HRQoL) measured by Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS)(1 day (once through survey))
- Treatment patterns of peri- and post-menopausal women assessed by type of treatment(1 day (once through survey))
- Proportion of Participants with VMS taking over the counter treatment for moderate to severe VMS symptoms(1 day (once through survey))
- Health Related Quality of Life (HRQoL) measured by Work Productivity and Activity Impairment-VMS (WPAI-VMS) Questionnaire(1 day (once through survey))
- Proportion of Participants incurring average out-of-pocket expenses incurred in treatment of menopause(1 day (once through survey))
- Health Related Quality of Life (HRQoL) measured by the Menopause Specific QoL Questionnaire (MENQoL)(1 day (once through survey))
- Proportion of Participants with VMS seeking healthcare professionals' (HCP) advice(1 day (once through survey))
- Percentage of peri-and post-menopausal women who seek help from HCPs for their menopause related symptoms (MR-VMS)(1 day (once through survey))
- Health Related Quality of Life (HRQoL) measured by participants' attitudes to their VMS(1 day (once through survey))
- Treatment patterns of peri- and post-menopausal assessed by length of time on hormonal treatment(1 day (once through survey))