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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

3399 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-09

Study Completion Date

2020-10-19

Brief Summary

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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

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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

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Menopause

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1: Peri-menopausal woman

Grouping is based on Peri-menopausal woman

No intervention

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)


* 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

* 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


* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Singapore Pte. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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 Status

Site KR82001

Seoul, , South Korea

Site Status

Site TW88601

Taipei, , Taiwan

Site Status

Countries

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China South Korea Taiwan

Other Identifiers

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2693-MA-3289

Identifier Type: -

Identifier Source: org_study_id

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