An observational study in Moderate to Severe Vasomotor Symptoms, sponsored by Astellas Pharma Europe Ltd.. Completed at 1 site in United Kingdom. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Astellas Pharma Europe Ltd. · Observational
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.
Astellas Pharma Europe Ltd. is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
post-menopausal women with moderate to severe VMS associated with menopause
Exclusion Criteria:
post-menopausal women with moderate to severe VMS associated with menopause
Other: No Intervention
This is a non-product related survey.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day (once through survey)
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.
Time frame: 1 day (once through survey)
Plan to share: 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/.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Europe Ltd.