A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)

Astellas Pharma Singapore Pte. Ltd.3,399 enrolled

Overview

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.

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

3,399

Conditions

Menopause

Interventions

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

Site CN86002

Beijing, China

Site KR82001

Seoul, South Korea

Site TW88601

Taipei, Taiwan

Outcomes

Primary Outcomes

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.