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

NCT04553029 | Completed

• 1 other identifier: 2693-MA-3289
• Study Type: observational
• Target: 3,399
• Locations: 3 countries
• Sites: 3

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.

Conditions

Menopause

Keywords

peri-menopausal; hormone replacement therapy; menopause; VMS; post-menopausal; menopausal; Vasomotor Symptoms; HRT

Outcome Measures

Primary Outcomes (7)

• 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.

  1 day (once through survey)

• Prevalence of moderate-to-severe Vasomotor Symptoms (VMS) in peri-menopausal women and post-menopausal women aged 40-65

  Prevalence of moderate-to-severe Vasomotor Symptoms (VMS) cases in peri-menopausal women and post-menopausal women aged 40-65 will be evaluated.

  1 day (once through survey)

• Severity of Vasomotor Symptoms (VMS) symptoms based on pre-defined definitions for severity among peri-menopausal women and post-menopausal women aged 40-65

  Severity of Vasomotor Symptoms (VMS) in peri-menopausal women and post-menopausal women aged 40-65 will be evaluated following the Food and Drug Administration (FDA) Guidelines. The severity of VMS symptoms may range from: absence of symptoms (no sensation of heat or sweating), mild (the sensation of feeling hot without sweating), moderate (the sensation of feeling hot, accompanied by sweating, and able to maintain activity), and severe (the sensation of feeling hot, accompanied by sweating, and needing to cease activity).

  1 day (once through survey)

• Proportion of participants Hormone Replacement Therapy (HRT) eligible and willing to take HRT

  Number of participants eligible and willing to take Hormone Replacement Therapy (HRT) compared to number of participants evaluated.

  1 day (once through survey)

• Proportion of participants Hormone Replacement Therapy (HRT) eligible and HRT averse

  Number of participants eligible and not willing to take Hormone Replacement Therapy (HRT) compared to number of participants evaluated.

  1 day (once through survey)

• Proportion of participants Hormone Replacement Therapy (HRT) ineligible due to contra-indications/high risk

  Number of participants ineligible to take Hormone Replacement Therapy (HRT) due to contra-indications/high risk compared to number of participants evaluated.

  1 day (once through survey)

• Proportion of participants that stopped Hormone Replacement Therapy (HRT)

  Number of participants that stopped Hormone Replacement Therapy (HRT) compared to number of participants evaluated.

  1 day (once through survey)

Secondary Outcomes (4)

• Health Related Quality of Life (HRQoL) measured by Menopause Specific Quality of Life Questionnaire (MENQOL)

  1 day (once through survey)

• Health Related Quality of Life (HRQoL) measured by Work Productivity and Activity Impairment (WPAI)

  1 day (once through survey)

• Health Related Quality of Life (HRQoL) measured by Treatment history related to menopause-related vasomotor symptoms (MR-VMS)

  1 day (once through survey)

• Health Related Quality of Life (HRQoL) measured by Patient attitudes towards prescription treatment choices in participants with moderate-to-severe MR-VMS

  1 day (once through survey)

Study Arms (4)

Group 1: Peri-menopausal woman

Grouping is based on Peri-menopausal woman

Other: No intervention

Group 2: Post- menopausal woman

Grouping is based on Post-menopausal woman

Other: No intervention

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)

Other: No intervention

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)

Other: No intervention

Interventions

No intervention 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 1: Peri-menopausal woman; Group 2: Post- menopausal woman; Group 3: Peri-menopausal woman: moderate-to-severe MR-VMS; Group 4: Post-menopausal woman: moderate-to-severe MR-VMS

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

peri-menopausal women and post-menopausal women aged 40-65 in East Asia (China, South Korea and Taiwan)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Singapore Pte. Ltd.: lead

Study Sites (3)

Site CN86002

Beijing, China

Location

Site KR82001

Seoul, South Korea

Location

Site TW88601

Taipei, Taiwan

Location

Study Officials

• Study Director

  Astellas Pharma Singapore Pte. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 17, 2020
• Study Start: September 9, 2020
• Primary Completion: October 19, 2020
• Study Completion: October 19, 2020
• Last Updated: October 16, 2024

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1); CN (1); TW (1)