Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04553029
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2020-09-14
Brief Title:
A Survey Evaluating Prevalence Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms MR-VMS
Sponsor:
Astellas Pharma Singapore Pte Ltd
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
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
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie not willing to take HRT HRT-ineligible due to contra-indicationshigh-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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None