A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
NCT ID: NCT04553029
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3399 participants
OBSERVATIONAL
2020-09-09
2020-10-19
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Group 1: Peri-menopausal woman
Grouping is based on Peri-menopausal woman
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
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)
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)
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Evidence of post-menopause (spontaneous amenorrhea over 12 months)
* 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
* Women who are currently participating or have participated in menopause-related vasomotor symptoms (MR-VMS) clinical trials
* 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
40 Years
65 Years
FEMALE
No
Sponsors
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Astellas Pharma Singapore Pte. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Astellas Pharma Singapore Pte. Ltd.
Locations
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Site CN86002
Beijing, , China
Site KR82001
Seoul, , South Korea
Site TW88601
Taipei, , Taiwan
Countries
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Other Identifiers
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2693-MA-3289
Identifier Type: -
Identifier Source: org_study_id
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