Moderate to Severe Vasomotor SymptomsNCT05300568
A Survey About Trade-offs When Choosing Menopause Treatments
An observational study of Moderate to Severe 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 menopause with moderate to severe hot flashes. Menopause, a normal part of life, is the 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
- Moderate to Severe Vasomotor Symptoms
- How many people
- 1,465 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Aug 2022to 27 Aug 2023
- 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: post-menopausal women with moderate to severe VMS associated with menopause
Who may be able to join
- Resident of Australia, Canada, Denmark, France, Germany, Italy, Spain, Sweden, or the United Kingdom
- Experience at least 14 moderate or severe VMS episodes associated with menopause per week (or 2 to 3 episodes per day)
- Self-reported completion of natural menopause (post-menopausal)
- Willing and able to provide consent to take part in the study; Speak native language of country of participation
- Telephone interview only: Willing and able to participate in a telephone interview, and be audio recorded
Who cannot join
- Experienced treatment related menopause either as a result of medical or surgical intervention
- Difficulty understanding or communicating in the language(s) of Australia, Canada, Denmark, France, Italy, Spain, Sweden, or the United Kingdom
- Online survey only: Participation in the Telephone interview
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Women's Treatment Preferences for Moderate to Severe Vasomotor Symptoms (VMS) (WARMER Study)
This study is an online survey of women in menopause with moderate to severe hot flashes. Menopause, a normal part of life, is the 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 on the trade-offs women are willing to make when deciding which treatment or treatments work best for them.
Read more
Women from Australia, Canada, Denmark, France, Germany, Italy, Spain, Sweden and the United Kingdom (UK) will take part in this study.
Women will be recruited through a third-party recruitment company.
Most women will be asked to complete an online survey. Before the survey is sent to the women in the study, it will be tested by a small group of women. This group will be asked to take part in a telephone interview while taking the survey. They will be asked to say their thoughts aloud while completing the survey. Researchers will record this and also take notes. The aim of the interview is to check that the survey is understood by the women before it is sent out to the rest of the women.
The survey will have 3 sections: Firstly, the women will answer questions about their experience with menopause and their symptoms. Next, they will be shown pros and cons for specific treatments for their menopause symptoms. The women will be asked to choose which treatment they would prefer, based on this information. Finally, they will answer questions on how their menopause symptoms have impacted their lives.
- Conditions
- Moderate to Severe 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 non-product related survey.
| Study group | Role | What they receive |
|---|---|---|
| post-menopausal women | post-menopausal women with moderate to severe VMS associated with menopause Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part-worth utilities for each treatment attribute
The effect of changes in each attribute on preferences.
Participants' preferences for Vasomotor Symptoms (VMS) treatment attributes will be collected via a discrete choice experiment (DCE).
Participants will be asked to choose their preferred option among two treatments or no treatment.
Negative part-worth utility indicates less desired levels and positive part-worth utility indicates more desired levels of attributes.
Measured: 1 day (once through survey)
Relative attribute importance scores
Relative attribute importance scores will be derived from part-worth estimates and measure the maximum percentage contribution to a preference that relates to a change in each attribute.
Measured: 1 day (once through survey)
Maximum acceptable risk
Maximum acceptable risk will be derived from part-worth estimates and measures how much risk (i.e., for each included risk) participants are willing to accept for a one-unit change in each other attribute.
Measured: 1 day (once through survey)
Minimum acceptable benefit
Minimum acceptable benefit will be derived from part-worth estimates and measures the minimum acceptable reduction in the frequency of VMS for a unit change in each other attribute.
Measured: 1 day (once through survey)
Secondary outcomes (1)
Estimated probability that a specific treatment profile will be chosen
A set of treatment profiles will be generated using the attributes included in the discrete choice experiment (DCE). The probability of each profile being selected will be calculated.
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 posted29 Mar 2022
- Study start17 Aug 2022
- Primary completion27 Aug 2023
- Study completion27 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Vasomotor SymptomsStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Director, Study director, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300568
- Sponsor's protocol ID
- 2693-MA-3237
- Status last verified
- Oct 2024
- First submitted
- 18 Mar 2022
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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/.
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
- Women's Treatment Preferences for Moderate to Severe Vasomotor Symptoms (VMS) (WARMER Study)
- ClinicalTrials.gov ID
- NCT05300568
- Acronym / sponsor ID
- 2693-MA-3237
- Conditions
- Moderate to Severe Vasomotor Symptoms
- Keywords
- menopause, vasomotor symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,465 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 27 Aug 2023 (actual)
- Study completion
- 27 Aug 2023 (actual)
- First posted
- 29 Mar 2022 (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 menopause with moderate to severe hot flashes. Menopause, a normal part of life, is the 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 on the trade-offs women are willing to make when deciding which treatment or treatments work best for them.
Women from Australia, Canada, Denmark, France, Germany, Italy, Spain, Sweden and the United Kingdom (UK) will take part in this study.
Women will be recruited through a third-party recruitment company.
Most women will be asked to complete an online survey. Before the survey is sent to the women in the study, it will be tested by a small group of women. This group will be asked to take part in a telephone interview while taking the survey. They will be asked to say their thoughts aloud while completing the survey. Researchers will record this and also take notes. The aim of the interview is to check that the survey is understood by the women before it is sent out to the rest of the women.
The survey will have 3 sections: Firstly, the women will answer questions about their experience with menopause and their symptoms. Next, they will be shown pros and cons for specific treatments for their menopause symptoms. The women will be asked to choose which treatment they would prefer, based on this information. Finally, they will answer questions on how their menopause symptoms have impacted their lives.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post-menopausal women | – | Other: No Interventionpost-menopausal women with moderate to severe VMS associated with menopause |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- post-menopausal women with moderate to severe VMS associated with menopause
Key inclusion criteria (5 listed)
- Resident of Australia, Canada, Denmark, France, Germany, Italy, Spain, Sweden, or the United Kingdom
- Experience at least 14 moderate or severe VMS episodes associated with menopause per week (or 2 to 3 episodes per day)
- Self-reported completion of natural menopause (post-menopausal)
- Willing and able to provide consent to take part in the study; Speak native language of country of participation
- Telephone interview only: Willing and able to participate in a telephone interview, and be audio recorded
Key exclusion criteria (3 listed)
- Experienced treatment related menopause either as a result of medical or surgical intervention
- Difficulty understanding or communicating in the language(s) of Australia, Canada, Denmark, France, Italy, Spain, Sweden, or the United Kingdom
- Online survey only: Participation in the Telephone interview
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 non-product related survey. | Other | post-menopausal women |
Primary outcome
Part-worth utilities for each treatment attribute
Time frame: 1 day (once through survey)
The effect of changes in each attribute on preferences. Participants' preferences for Vasomotor Symptoms (VMS) treatment attributes will be collected via a discrete choice experiment (DCE). Participants will be asked to choose their preferred option among two treatments or no treatment. Negative part-worth utility indicates less desired levels and positive part-worth utility indicates more desired levels of attributes.
Relative attribute importance scores
Time frame: 1 day (once through survey)
Relative attribute importance scores will be derived from part-worth estimates and measure the maximum percentage contribution to a preference that relates to a change in each attribute.
Maximum acceptable risk
Time frame: 1 day (once through survey)
Maximum acceptable risk will be derived from part-worth estimates and measures how much risk (i.e., for each included risk) participants are willing to accept for a one-unit change in each other attribute.
Minimum acceptable benefit
Time frame: 1 day (once through survey)
Minimum acceptable benefit will be derived from part-worth estimates and measures the minimum acceptable reduction in the frequency of VMS for a unit change in each other attribute.
1 secondary outcome
Estimated probability that a specific treatment profile will be chosen
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.
- 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 Moderate to Severe Vasomotor Symptoms
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Hot Flashes
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Active, not recruitingPhase 3
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
Hot Flashes
RecruitingPhase 2
Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).
Vasomotor Symptoms
RecruitingPhase 2
Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer
Prostate CA, Androgen Deprivation Therapy
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.
Senior Director study director
Astellas Pharma Europe Ltd.
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 Moderate to Severe 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 5 inclusion and 3 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?
Part-worth utilities for each treatment attribute (time frame: 1 day (once through survey)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.