MenopauseNCT05083884
A Survey About Hot Flashes in Women Going Through the Menopause
An observational study of Menopause and Vasomotor Symptoms, run by Astellas Pharma Europe Ltd. at 1 site in United Kingdom.
Trial summary
This study is an online survey of women in and around menopause with moderate to severe hot flashes. Menopause, a normal part of life, is a time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life. This study is about collecting information only. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopause, Vasomotor Symptoms
- How many people
- 2,176 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Nov 2021to 17 Jan 2022
- 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- and post-menopausal women with moderate to severe VMS symptoms
Who may be able to join
- Post-menopausal women
- Women currently experiencing, or have experienced in the last month, moderate to severe VMS symptoms (i.e. minimum of 1 moderate to severe hot flushes per day over the last month)
- Peri-menopausal and post-menopausal women
Who cannot join
- Women with current breast cancer treatment
- Women treated with anti-estrogens, aromatase inhibitors or Gonadotropin-releasing hormone (GnRH) agonists/antagonists for cancer or any other medical condition.
- Additional exclusion criterion for secondary outcome measures will be:
- Mild VMS symptoms only
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Survey of Women With Vasomotor Symptoms Associated With Menopause in Nordic Europe, Canada, Brazil and Mexico - WARM Study
This study is an online survey of women in and around menopause with moderate to severe hot flashes. Menopause, a normal part of life, is a time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life.
This study is about collecting information only. There will be no treatment in this study.
Read more
This study will provide information about how many women have moderate to severe hot flashes in menopause. It will also provide details on women's experiences with hot flashes.
Women from Brazil, Canada, Nordic Europe, and Mexico will take part in this study. The women in this study will already be taking part in consumer panels. Women will be contacted based on their age. They will be asked if they would like to take part in this study.
Firstly, the women will answer questions about whether they are in menopause or are getting close to menopause. They will also be asked how severe their hot flashes are.
From their answers, some women will be asked to complete an online survey. These will be women who are in menopause and have moderate to severe hot flashes. They will provide more details about how hot flashes have impacted their lives. Also, they will answer questions on how hot flashes affect their quality of life. Finally, they will answer questions about their experiences when they visited their doctor about their hot flashes.
- Conditions
- Menopause, Vasomotor Symptoms
- Being tested
- No Intervention
- Keywords
- Menopause, Vasomotor Symptoms
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 non-product related survey including peri- and post-menopausal women with moderate to severe VMS associated with menopause.
| 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 moderate to severe vasomotor symptoms (VMS) in post-menopausal women
Prevalence of moderate to severe VMS in post-menopausal women. Post-menopause is defined as at least 12 consecutive months without a period. Moderate VMS associated with menopause symptoms is defined as sensations of heat with sweating but being able to continue activities. Severe VMS associated with menopause is defined as feelings of intense heat with sweating causing cessation of activities. The recall period is 1 month prior to survey.
Measured: 1 day (once through survey)
Secondary outcomes (10)
Health Related Quality of Life (HRQoL) measured by the Menopause Specific QoL Questionnaire (MENQoL)
MENQoL measures the overall score and four domain-specific scores assessing wellbeing (vasomotor; psychosocial; physical; sexual). Scores range from 1 to 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-VMS (WPAI-VMS) Questionnaire
The WPAI-VMS questionnaire 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 Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS)
The PROMIS Sleep Disturbance instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Each item on the measure is rated on a 5-point scale with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance. The PROMIS recall period is 7 days prior to survey.
(Only implemented in Canada, Brazil and Denmark).
Measured: 1 day (once through survey)
Proportion of Participants with VMS seeking healthcare professionals' (HCP) advice
The type of specialists reported by peri- and post-menopausal women will be assessed.
Measured: 1 day (once through survey)
Proportion of Participants with VMS taking over the counter treatment for moderate to severe VMS symptoms
The types of over the counter treatment taken by peri- and post-menopausal women for MR symptoms will be assessed.
Measured: 1 day (once through survey)
Proportion of Participants incurring average out-of-pocket expenses incurred in treatment of menopause
Average out-of-pocket expenses incurred in the treatment of menopause reported by medications bought will be assessed.
Measured: 1 day (once through survey)
Percentage of peri-and post-menopausal women who seek help from HCPs for their menopause related symptoms (MR-VMS)
Percentage of peri- and post-menopausal women who seek help from Health Care Professionals (HCPs) for their MR-VMS. Help from an HCP can be in the form of advice or receipt of pharmaceutical treatment.
Measured: 1 day (once through survey)
Health Related Quality of Life (HRQoL) measured by participants' attitudes to their VMS
Participants' attitudes towards their VMS will be evaluated using the following: agreement or disagreement to statements on menopause itself, available treatments, and willingness/aversion to hormone replacement therapy (HRT).
Measured: 1 day (once through survey)
Treatment patterns of peri- and post-menopausal women assessed by type of treatment
The number of peri- and post-menopausal women treated with hormonal treatment, non-hormonal treatment, or other approaches will be summarized.
Measured: 1 day (once through survey)
Treatment patterns of peri- and post-menopausal assessed by length of time on hormonal treatment
The length of time on hormonal treatment in peri- and post-menopausal women will be summarized.
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.
- First posted19 Oct 2021
- Study start4 Nov 2021
- Primary completion17 Jan 2022
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 2,176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Medical Affairs Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083884
- Sponsor's protocol ID
- 2693-MA-3235
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2021
- Last updated
- 26 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/.
Publications
Todorova L, Bonassi R, Guerrero Carreno FJ, Hirschberg AL, Yuksel N, Rea C, Scrine L, Kim JS. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179-1189. doi: 10.1097/GME.0000000000002265. Epub 2023 Oct 19.
PubMed 37847872
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Survey of Women With Vasomotor Symptoms Associated With Menopause in Nordic Europe, Canada, Brazil and Mexico - WARM Study
- ClinicalTrials.gov ID
- NCT05083884
- Acronym / sponsor ID
- 2693-MA-3235
- Conditions
- Menopause, Vasomotor Symptoms
- Keywords
- Menopause, Vasomotor Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,176 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 19 Oct 2021 (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.
This study is an online survey of women in and around menopause with moderate to severe hot flashes. Menopause, a normal part of life, is a time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life.
This study is about collecting information only. There will be no treatment in this study.
This study will provide information about how many women have moderate to severe hot flashes in menopause. It will also provide details on women's experiences with hot flashes.
Women from Brazil, Canada, Nordic Europe, and Mexico will take part in this study. The women in this study will already be taking part in consumer panels. Women will be contacted based on their age. They will be asked if they would like to take part in this study.
Firstly, the women will answer questions about whether they are in menopause or are getting close to menopause. They will also be asked how severe their hot flashes are.
From their answers, some women will be asked to complete an online survey. These will be women who are in menopause and have moderate to severe hot flashes. They will provide more details about how hot flashes have impacted their lives. Also, they will answer questions on how hot flashes affect their quality of life. Finally, they will answer questions about their experiences when they visited their doctor about their hot flashes.
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- and post-menopausal women with moderate to severe VMS symptoms
Key inclusion criteria (3 listed)
- Post-menopausal women
- Women currently experiencing, or have experienced in the last month, moderate to severe VMS symptoms (i.e. minimum of 1 moderate to severe hot flushes per day over the last month)
- Peri-menopausal and post-menopausal women
Key exclusion criteria (4 listed)
- Women with current breast cancer treatment
- Women treated with anti-estrogens, aromatase inhibitors or Gonadotropin-releasing hormone (GnRH) agonists/antagonists for cancer or any other medical condition.
- Mild VMS symptoms 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 non-product related survey including peri- and post-menopausal women with moderate to severe VMS associated with menopause. | 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 moderate to severe vasomotor symptoms (VMS) in post-menopausal women
Time frame: 1 day (once through survey)
Prevalence of moderate to severe VMS in post-menopausal women. Post-menopause is defined as at least 12 consecutive months without a period. Moderate VMS associated with menopause symptoms is defined as sensations of heat with sweating but being able to continue activities. Severe VMS associated with menopause is defined as feelings of intense heat with sweating causing cessation of activities. The recall period is 1 month prior to survey.
10 secondary outcomes
Health Related Quality of Life (HRQoL) measured by the Menopause Specific QoL Questionnaire (MENQoL)
Time frame: 1 day (once through survey)
Health Related Quality of Life (HRQoL) measured by Work Productivity and Activity Impairment-VMS (WPAI-VMS) Questionnaire
Time frame: 1 day (once through survey)
Health Related Quality of Life (HRQoL) measured by Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS)
Time frame: 1 day (once through survey)
Proportion of Participants with VMS seeking healthcare professionals' (HCP) advice
Time frame: 1 day (once through survey)
Proportion of Participants with VMS taking over the counter treatment for moderate to severe VMS symptoms
Time frame: 1 day (once through survey)
Proportion of Participants incurring average out-of-pocket expenses incurred in treatment of menopause
Time frame: 1 day (once through survey)
Percentage of peri-and post-menopausal women who seek help from HCPs for their menopause related symptoms (MR-VMS)
Time frame: 1 day (once through survey)
Health Related Quality of Life (HRQoL) measured by participants' attitudes to their VMS
Time frame: 1 day (once through survey)
Treatment patterns of peri- and post-menopausal women assessed by type of treatment
Time frame: 1 day (once through survey)
Treatment patterns of peri- and post-menopausal assessed by length of time on hormonal treatment
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 26 Oct 2024.
- Derived from this study: PubMed 37847872Todorova L, Bonassi R, Guerrero Carreno FJ, Hirschberg AL, Yuksel N, Rea C, Scrine L, Kim JS. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179-1189. doi: 10.1097/GME.0000000000002265. Epub 2023 Oct 19.
- Link to results and other applicable study documents on the Astellas Clinical Trials websiteLink provided by the sponsor.
- 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/.
Related trials for Menopause
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
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.
Medical Director study director
Medical Affairs Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Vasomotor Symptoms, run by Astellas Pharma Europe Ltd. at 1 site in United Kingdom.
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 26 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 1 site in United Kingdom. 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 moderate to severe vasomotor symptoms (VMS) in post-menopausal women (time frame: 1 day (once through survey)). 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 NCT05083884, which also lists 1 linked publication.
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 26 Oct 2024.