CompletedNot Applicable

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

China, South Korea, Taiwan3,399 participantsStarted 2020-09-09

Plain-language 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.

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 day (once through survey)

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)

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)

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

Timeframe: 1 day (once through survey)

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

Timeframe: 1 day (once through survey)

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

Timeframe: 1 day (once through survey)

Trial details

NCT IDNCT04553029

SponsorAstellas Pharma Singapore Pte. Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-10-19

View on ClinicalTrials.gov More Menopause trials

Plain-language summary

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 1 day (once through survey)

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)

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)

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

Timeframe: 1 day (once through survey)

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

Timeframe: 1 day (once through survey)

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

Timeframe: 1 day (once through survey)