A Cross-sectional Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate To-severe Menopause-related Vasomotor Symptoms (MR-VMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,399
- 试验地点
- 3
- 主要终点
- Severity of Vasomotor Symptoms (VMS) symptoms based on pre-defined definitions for severity among peri-menopausal women and post-menopausal women aged 40-65
研究概览
简要总结
The purpose of this study is to estimate the prevalence of Vasomotor Symptoms (VMS) and prevalence of moderate to severe VMS in peri-menopausal women and post-menopausal women aged 40-65 in East Asia (China, South Korea and Taiwan) and the proportion of the following subpopulations: Hormone Replacement Therapy (HRT)-eligible and willing to take HRT; HRT-eligible and HRT-averse (i.e. not willing to take HRT); HRT-ineligible due to contra-indications/high-risk; and HRT-stoppers.
The study will also assess Health Related Quality of Life (HRQoL) and VMS related productivity loss among perimenopausal and post-menopausal women with moderate-to-severe MR-VMS and the respondents' attitudes toward prescription treatments.
详细描述
The study will recruit women of 40-65 years old from an established consumer panel in China, South Korea, and Taiwan.
Women who meet the inclusion criteria for Part I will be recruited to sign the informed consent form (ICF) and participate in Part I of the survey.
Based on the information collected in Part I of the survey, peri- and post-menopausal women who meet the inclusion criteria for Part II will be directed to Part II of the survey. The survey will be terminated for women who do not meet the inclusion criteria for Part II.
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
Severity of Vasomotor Symptoms (VMS) symptoms based on pre-defined definitions for severity among peri-menopausal women and post-menopausal women aged 40-65
时间窗: 1 day (once through survey)
Severity of Vasomotor Symptoms (VMS) in peri-menopausal women and post-menopausal women aged 40-65 will be evaluated following the Food and Drug Administration (FDA) Guidelines. The severity of VMS symptoms may range from: absence of symptoms (no sensation of heat or sweating), mild (the sensation of feeling hot without sweating), moderate (the sensation of feeling hot, accompanied by sweating, and able to maintain activity), and severe (the sensation of feeling hot, accompanied by sweating, and needing to cease activity).
Prevalence of moderate-to-severe Vasomotor Symptoms (VMS) in peri-menopausal women and post-menopausal women aged 40-65
时间窗: 1 day (once through survey)
Prevalence of moderate-to-severe Vasomotor Symptoms (VMS) cases in peri-menopausal women and post-menopausal women aged 40-65 will be evaluated.
Prevalence of Vasomotor Symptoms (VMS) in peri-menopausal women and post-menopausal women aged 40-65
时间窗: 1 day (once through survey)
Prevalence of VMS in peri-menopausal women and post-menopausal women aged 40-65. Peri-menopause is defined as changes in the regular period in terms of irregularity in the length of the period, the time between periods, and the level of flow. Post-menopause is defined as spontaneous amenorrhea over 12 months.
Proportion of participants Hormone Replacement Therapy (HRT) eligible and HRT averse
时间窗: 1 day (once through survey)
Number of participants eligible and not willing to take Hormone Replacement Therapy (HRT) compared to number of participants evaluated.
Proportion of participants Hormone Replacement Therapy (HRT) ineligible due to contra-indications/high risk
时间窗: 1 day (once through survey)
Number of participants ineligible to take Hormone Replacement Therapy (HRT) due to contra-indications/high risk compared to number of participants evaluated.
Proportion of participants Hormone Replacement Therapy (HRT) eligible and willing to take HRT
时间窗: 1 day (once through survey)
Number of participants eligible and willing to take Hormone Replacement Therapy (HRT) compared to number of participants evaluated.
Proportion of participants that stopped Hormone Replacement Therapy (HRT)
时间窗: 1 day (once through survey)
Number of participants that stopped Hormone Replacement Therapy (HRT) compared to number of participants evaluated.
次要结局
- Health Related Quality of Life (HRQoL) measured by Menopause Specific Quality of Life Questionnaire (MENQOL)(1 day (once through survey))
- Health Related Quality of Life (HRQoL) measured by Treatment history related to menopause-related vasomotor symptoms (MR-VMS)(1 day (once through survey))
- Health Related Quality of Life (HRQoL) measured by Work Productivity and Activity Impairment (WPAI)(1 day (once through survey))
- Health Related Quality of Life (HRQoL) measured by Patient attitudes towards prescription treatment choices in participants with moderate-to-severe MR-VMS(1 day (once through survey))