Clinical trial NCT04553029: A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Keywords: peri-menopausal
hormone replacement therapy
menopause
VMS
post-menopausal
menopausal
Vasomotor Symptoms
HRT
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2020-09-17
Enrollment: 3399
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: peri-menopausal women and post-menopausal women aged 40-65 in East Asia (China, South Korea and Taiwan)

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 (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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Vasomotor Symptoms (VMS) in peri-menopausal women and post-menopausal women aged 40-65
timeFrame: 1 day (once through survey)
measure: Prevalence of moderate-to-severe Vasomotor Symptoms (VMS) in peri-menopausal women and post-menopausal women aged 40-65
timeFrame: 1 day (once through survey)
measure: Severity of Vasomotor Symptoms (VMS) symptoms based on pre-defined definitions for severity among peri-menopausal women and post-menopausal women aged 40-65
timeFrame: 1 day (once through survey)
measure: Proportion of participants Hormone Replacement Therapy (HRT) eligible and willing to take HRT
timeFrame: 1 day (once through survey)
measure: Proportion of participants Hormone Replacement Therapy (HRT) eligible and HRT averse
timeFrame: 1 day (once through survey)
measure: Proportion of participants Hormone Replacement Therapy (HRT) ineligible due to contra-indications/high risk
timeFrame: 1 day (once through survey)
measure: Proportion of participants that stopped Hormone Replacement Therapy (HRT)
timeFrame: 1 day (once through survey)
Secondary outcomes:
measure: Health Related Quality of Life (HRQoL) measured by Menopause Specific Quality of Life Questionnaire (MENQOL)
timeFrame: 1 day (once through survey)
measure: Health Related Quality of Life (HRQoL) measured by Work Productivity and Activity Impairment (WPAI)
timeFrame: 1 day (once through survey)
measure: Health Related Quality of Life (HRQoL) measured by Treatment history related to menopause-related vasomotor symptoms (MR-VMS)
timeFrame: 1 day (once through survey)
measure: Health Related Quality of Life (HRQoL) measured by Patient attitudes towards prescription treatment choices in participants with moderate-to-severe MR-VMS
timeFrame: 1 day (once through survey)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Site CN86002
city: Seoul
country: Korea, Republic of
facility: Site KR82001
city: Taipei
country: Taiwan
facility: Site TW88601
Study officials:
affiliation: Astellas Pharma Singapore Pte. Ltd.
name: Study Director
role: STUDY_DIRECTOR
References: