No intervention
OtherThis is a cross-sectional survey study evaluating prevalence, severity and associated factors in women with moderate-to-severe menopause-related vasomotor symptoms (MR-VMS).
NCT Number: NCT04553029
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.
Looking for future studies?
Notify Me40 year–65 year
Female
Observational
Site CN86002, Beijing, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(part I):
Inclusion criteria
(part II):
Exclusion criteria
(part I):
Exclusion criteria
(part II):
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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 1 day (once through survey)
Number of participants eligible and willing to take Hormone Replacement Therapy (HRT) compared to number of participants evaluated.
Time frame: 1 day (once through survey)
Number of participants eligible and not willing to take Hormone Replacement Therapy (HRT) compared to number of participants evaluated.
Time frame: 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.
Time frame: 1 day (once through survey)
Number of participants that stopped Hormone Replacement Therapy (HRT) compared to number of participants evaluated.
Time frame: 1 day (once through survey)
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.
Time frame: 1 day (once through survey)
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.
Time frame: 1 day (once through survey)
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).
Time frame: 1 day (once through survey)
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).
Astellas Pharma Singapore Pte. Ltd.
Industry
A Cross-sectional Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate To-severe Menopause-related Vasomotor Symptoms (MR-VMS)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07695051
Hot Flashes, Menopause
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07589335
African Americans, Community Health Workers
Atlanta, Georgia, United States
View Trial DetailsNCT07651566
Menopause, Pathologic Processes
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT02618148
Menopause
Ho Chi Minh City, Vietnam
View Trial Details