Clinical trial NCT05300568: A Survey About Trade-offs When Choosing Menopause Treatments
Official title: Women's Treatment Preferences for Moderate to Severe Vasomotor Symptoms (VMS) (WARMER Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate to Severe Vasomotor Symptoms
Keywords: menopause
vasomotor symptoms
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 1465
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: post-menopausal women with moderate to severe VMS associated with menopause

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Part-worth utilities for each treatment attribute
timeFrame: 1 day (once through survey)
measure: Relative attribute importance scores
timeFrame: 1 day (once through survey)
measure: Maximum acceptable risk
timeFrame: 1 day (once through survey)
measure: Minimum acceptable benefit
timeFrame: 1 day (once through survey)
Secondary outcomes:
measure: Estimated probability that a specific treatment profile will be chosen
timeFrame: 1 day (once through survey)
Other outcomes:
Locations:
city: Hammersmith
country: United Kingdom
facility: Site GB44001
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Senior Director
role: STUDY_DIRECTOR
References: