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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Peri-menopausal woman | Grouping is based on Peri-menopausal woman |
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| Group 2: Post- menopausal woman | Grouping is based on Post-menopausal woman |
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| Group 3: Peri-menopausal woman: moderate-to-severe MR-VMS | Grouping is based on Peri-menopausal woman with moderate-to-severe vasomotor symptoms (MR-VMS) |
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| Group 4: Post-menopausal woman: moderate-to-severe MR-VMS | Grouping is based on Post-menopausal woman with moderate-to-severe vasomotor symptoms (MR-VMS) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | This is a cross-sectional survey study evaluating prevalence, severity and associated factors in women with moderate-to-severe menopause-related vasomotor symptoms (MR-VMS). |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Vasomotor Symptoms (VMS) in peri-menopausal women and post-menopausal women aged 40-65 | 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. | 1 day (once through survey) |
| Prevalence of moderate-to-severe Vasomotor Symptoms (VMS) in peri-menopausal women and post-menopausal women aged 40-65 | Prevalence of moderate-to-severe Vasomotor Symptoms (VMS) cases in peri-menopausal women and post-menopausal women aged 40-65 will be evaluated. | 1 day (once through survey) |
| Severity of Vasomotor Symptoms (VMS) symptoms based on pre-defined definitions for severity among peri-menopausal women and post-menopausal women aged 40-65 | 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). | 1 day (once through survey) |
| Proportion of participants Hormone Replacement Therapy (HRT) eligible and willing to take HRT | Number of participants eligible and willing to take Hormone Replacement Therapy (HRT) compared to number of participants evaluated. | 1 day (once through survey) |
| Proportion of participants Hormone Replacement Therapy (HRT) eligible and HRT averse |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life (HRQoL) measured by Menopause Specific Quality of Life Questionnaire (MENQOL) | The Menopause Specific Quality of Life Questionnaire (MENQOL) measures the overall score and four domain-specific scores assessing wellbeing (Vasomotor; Psychosocial; Physical; Sexual). Scores range from 1-8 with a higher score indicating worsening/increasing bothersomeness by the symptom experience. The MENQOL recall period is 7 days prior to survey. |
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Inclusion Criteria (part I):
Inclusion Criteria (part II):
Exclusion Criteria (part I):
Exclusion Criteria (part II):
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peri-menopausal women and post-menopausal women aged 40-65 in East Asia (China, South Korea and Taiwan)
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Astellas Pharma Singapore Pte. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site CN86002 | Beijing | China | ||||
| Site KR82001 |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Number of participants eligible and not willing to take Hormone Replacement Therapy (HRT) compared to number of participants evaluated. |
| 1 day (once through survey) |
| Proportion of participants Hormone Replacement Therapy (HRT) ineligible due to contra-indications/high risk | Number of participants ineligible to take Hormone Replacement Therapy (HRT) due to contra-indications/high risk compared to number of participants evaluated. | 1 day (once through survey) |
| Proportion of participants that stopped Hormone Replacement Therapy (HRT) | Number of participants that stopped Hormone Replacement Therapy (HRT) compared to number of participants evaluated. | 1 day (once through survey) |
| 1 day (once through survey) |
| Health Related Quality of Life (HRQoL) measured by Work Productivity and Activity Impairment (WPAI) | The Work Productivity and Activity Impairment (WPAI) measures Four domain specific scores assessing work productivity and activity impairment over the previous week (Absenteeism; Presenteeism; Mean work productivity; Activity impairment). Scores range from 0 to 100%. The four scores were expressed as impairment percentages with a higher score indicating less productivity and greater activity impairment. The WPAI recall period is 7 days prior to survey. | 1 day (once through survey) |
| Health Related Quality of Life (HRQoL) measured by Treatment history related to menopause-related vasomotor symptoms (MR-VMS) | Menopause-related vasomotor symptoms (MR-VMS) treatment history will be evaluated by Hospital/clinics visiting history related to MR-VMS; past treatments and current treatments (e.g., hormone therapy, antidepressants, herbal medicine, acupuncture). | 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 | Patient attitudes towards prescription treatment choices will be evaluated using the following reasons/ factors: Reasons for seeking /not seeking treatments; Reasons for visiting/not visiting hospital/clinics; Awareness of long-term health risks if remain untreated; Willingness to seek for care/treatment if patients were aware of long-term health risks associated with leaving moderate-to-severe MR-VMS untreated; Reasons for choosing the current prescription treatments; Reasons for discontinuation of the previous prescription treatment; Factors determining prescription treatment choices and preference (for those who are not currently receiving treatment); Willingness toward new pharmacologic treatments; Key concerns of new pharmacologic treatments (for those who are not willing to try new treatment); and Key expectations of new pharmacologic treatments (for those willing to try new treatment). | 1 day (once through survey) |
| Seoul |
| South Korea |
| Site TW88601 | Taipei | Taiwan |