NCT04553029

A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)

A Cross-sectional Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate To-severe Menopause-related Vasomotor Symptoms (MR-VMS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,399 (actual)
• Sponsor: Astellas Pharma Singapore Pte. Ltd. · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Menopause

Interventions

Type	Name	Description
OTHER	No intervention	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).

Timeline

• Start date: 2020-09-09
• Primary completion: 2020-10-19
• Completion: 2020-10-19
• First posted: 2020-09-17
• Last updated: 2024-10-16

Locations

3 sites across 3 countries: China, South Korea, Taiwan