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

Astellas

Status

Completed

Conditions

Menopause

Treatments

Other: No intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT04553029

2693-MA-3289

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,399 patients

Sex

Female

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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