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)

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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 3399

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Site CN86002
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Site KR82001
• Taiwan
  • Taipei, Taiwan
    • Site TW88601

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

peri-menopausal women and post-menopausal women aged 40-65 in East Asia (China, South Korea and Taiwan)

Description

Inclusion Criteria (part I):

• Evidence of peri-menopause (changes in the regular period in terms of irregularity in the length of the period, the time between periods, and the level of flow), or
• Evidence of post-menopause (spontaneous amenorrhea over 12 months)

Inclusion Criteria (part II):

• Presence of moderate-to-severe menopause-related vasomotor symptoms (MR-VMS); Moderate: sensation of heat with sweating, able to continue activity; Severe: sensation of heat with sweating, causing cessation of activity)

Exclusion Criteria (part I):

• No evidence of peri-menopause or post-menopause, or
• Women who are currently participating or have participated in menopause-related vasomotor symptoms (MR-VMS) clinical trials

Exclusion Criteria (part II):

• Subjects who are treated with tamoxifen, aromatase inhibitors or Gonadotropin-releasing hormone (GnRH) agonists/antagonists for cancer or any other medical condition, or
• Subjects who have mild menopause-related vasomotor symptoms (MR-VMS) only

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: Peri-menopausal woman; Grouping is based on Peri-menopausal woman	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).
Group 2: Post- menopausal woman; Grouping is based on Post-menopausal woman	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).
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)	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).
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)	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Astellas Pharma Singapore Pte. Ltd.
• Investigators: Study Director: Study Director, Astellas Pharma Singapore Pte. Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2020
• Primary Completion (ACTUAL): October 19, 2020
• Study Completion (ACTUAL): October 19, 2020

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (ACTUAL): September 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: menopause; hormone replacement therapy; Vasomotor Symptoms; HRT; post-menopausal; menopausal; peri-menopausal; VMS
• Other Study ID Numbers: 2693-MA-3289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No