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

An observational study of Menopause, run by Astellas Pharma Singapore Pte. Ltd. at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 40 to 65 years, women only
Conditions the study is for: Menopause
How many people: 3,399 participants
Where: 3 sitesin 3 countries
Study dates: 9 Sep 2020to 19 Oct 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 65 years
Women only
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

China1 site

Site CN86002
Beijing

Other trials in China

South Korea1 site

Site KR82001
Seoul

Other trials in South Korea

Taiwan1 site

Site TW88601
Taipei

Other trials in Taiwan

About this study

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)

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.

Read the 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.

Conditions: Menopause
Being tested: No intervention
Keywords: peri-menopausal, hormone replacement therapy, menopause, VMS, post-menopausal, menopausal, Vasomotor Symptoms, HRT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionOther
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).

Study groups in NCT04553029
Study group	Role	What they receive
Group 1: Peri-menopausal woman		Grouping is based on Peri-menopausal woman Receives: Other: No intervention
Group 2: Post- menopausal woman		Grouping is based on Post-menopausal woman Receives: 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) Receives: 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) Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day (once through survey)

Secondary outcomes (4)

Health Related Quality of Life (HRQoL) measured by Menopause Specific Quality of Life Questionnaire (MENQOL)
The Menopause Specific Quality of Life Questionnaire (MENQOL) measures the overall score and four domain-specific scores assessing wellbeing (Vasomotor; Psychosocial; Physical; Sexual). Scores range from 1-8 with a higher score indicating worsening/increasing bothersomeness by the symptom experience. The MENQOL recall period is 7 days prior to survey.
Measured: 1 day (once through survey)
Health Related Quality of Life (HRQoL) measured by Work Productivity and Activity Impairment (WPAI)
The Work Productivity and Activity Impairment (WPAI) measures Four domain specific scores assessing work productivity and activity impairment over the previous week (Absenteeism; Presenteeism; Mean work productivity; Activity impairment). Scores range from 0 to 100%. The four scores were expressed as impairment percentages with a higher score indicating less productivity and greater activity impairment. The WPAI recall period is 7 days prior to survey.
Measured: 1 day (once through survey)
Health Related Quality of Life (HRQoL) measured by Treatment history related to menopause-related vasomotor symptoms (MR-VMS)
Menopause-related vasomotor symptoms (MR-VMS) treatment history will be evaluated by Hospital/clinics visiting history related to MR-VMS; past treatments and current treatments (e.g., hormone therapy, antidepressants, herbal medicine, acupuncture).
Measured: 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
Patient attitudes towards prescription treatment choices will be evaluated using the following reasons/ factors: Reasons for seeking /not seeking treatments; Reasons for visiting/not visiting hospital/clinics; Awareness of long-term health risks if remain untreated; Willingness to seek for care/treatment if patients were aware of long-term health risks associated with leaving moderate-to-severe MR-VMS untreated; Reasons for choosing the current prescription treatments; Reasons for discontinuation of the previous prescription treatment; Factors determining prescription treatment choices and preference (for those who are not currently receiving treatment); Willingness toward new pharmacologic treatments; Key concerns of new pharmacologic treatments (for those who are not willing to try new treatment); and Key expectations of new pharmacologic treatments (for those willing to try new treatment).
Measured: 1 day (once through survey)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 202019 Oct 2020

First posted17 Sep 2020
Study start9 Sep 2020
Primary completion19 Oct 2020
Study completion19 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MenopauseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 3,399 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04553029
Sponsor's protocol ID: 2693-MA-3289
Status last verified: Nov 2020
First submitted: 14 Sep 2020
Last updated: 16 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Menopause trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04553029
Acronym / sponsor ID: 2693-MA-3289
Conditions: Menopause
Keywords: peri-menopausal, hormone replacement therapy, menopause, VMS, post-menopausal, menopausal, Vasomotor Symptoms, HRT
Study type: Observational
Recruitment status: Completed
Enrolment: 3,399 participants (actual)
Lead sponsor: Astellas Pharma Singapore Pte. Ltd.Industry (pharma, biotech, devices)
Study start: 9 Sep 2020 (actual)
Primary completion: 19 Oct 2020 (actual)
Study completion: 19 Oct 2020 (actual)
First posted: 17 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 4

Arm	Type	Receives
Group 1: Peri-menopausal woman	–	Other: No interventionGrouping is based on Peri-menopausal woman
Group 2: Post- menopausal woman	–	Other: No interventionGrouping is based on Post-menopausal woman
Group 3: Peri-menopausal woman: moderate-to-severe MR-VMS	–	Other: No interventionGrouping is based on Peri-menopausal woman with moderate-to-severe vasomotor symptoms (MR-VMS)
Group 4: Post-menopausal woman: moderate-to-severe MR-VMS	–	Other: No interventionGrouping is based on Post-menopausal woman with moderate-to-severe vasomotor symptoms (MR-VMS)

Who may qualify

Ages: 40 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: peri-menopausal women and post-menopausal women aged 40-65 in East Asia (China, South Korea and Taiwan)

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No interventionThis is a cross-sectional survey study evaluating prevalence, severity and associated factors in women with moderate-to-severe menopause-related vasomotor symptoms (MR-VMS).	Other	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

Primary outcome

Prevalence of Vasomotor Symptoms (VMS) in peri-menopausal women and post-menopausal women aged 40-65
Time frame: 1 day (once through survey)
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.
Prevalence of moderate-to-severe Vasomotor Symptoms (VMS) in peri-menopausal women and post-menopausal women aged 40-65
Time frame: 1 day (once through survey)
Prevalence of moderate-to-severe Vasomotor Symptoms (VMS) cases in peri-menopausal women and post-menopausal women aged 40-65 will be evaluated.
Severity of Vasomotor Symptoms (VMS) symptoms based on pre-defined definitions for severity among peri-menopausal women and post-menopausal women aged 40-65
Time frame: 1 day (once through survey)
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).
Proportion of participants Hormone Replacement Therapy (HRT) eligible and willing to take HRT
Time frame: 1 day (once through survey)
Number of participants eligible and willing to take Hormone Replacement Therapy (HRT) compared to number of participants evaluated.
Proportion of participants Hormone Replacement Therapy (HRT) eligible and HRT averse
Time frame: 1 day (once through survey)
Number of participants eligible and not willing to take Hormone Replacement Therapy (HRT) compared to number of participants evaluated.
Proportion of participants Hormone Replacement Therapy (HRT) ineligible due to contra-indications/high risk
Time frame: 1 day (once through survey)
Number of participants ineligible to take Hormone Replacement Therapy (HRT) due to contra-indications/high risk compared to number of participants evaluated.
Proportion of participants that stopped Hormone Replacement Therapy (HRT)
Time frame: 1 day (once through survey)
Number of participants that stopped Hormone Replacement Therapy (HRT) compared to number of participants evaluated.

4 secondary outcomes

Health Related Quality of Life (HRQoL) measured by Menopause Specific Quality of Life Questionnaire (MENQOL)
Time frame: 1 day (once through survey)
Health Related Quality of Life (HRQoL) measured by Work Productivity and Activity Impairment (WPAI)
Time frame: 1 day (once through survey)
Health Related Quality of Life (HRQoL) measured by Treatment history related to menopause-related vasomotor symptoms (MR-VMS)
Time frame: 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
Time frame: 1 day (once through survey)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Astellas Pharma Singapore Pte. Ltd.

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Menopause, run by Astellas Pharma Singapore Pte. Ltd. at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of Vasomotor Symptoms (VMS) in peri-menopausal women and post-menopausal women aged 40-65 (time frame: 1 day (once through survey)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04553029.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.