A Survey About Trade-offs When Choosing Menopause Treatments

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.

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 Overview

• Status: Completed
• Conditions: Moderate to Severe Vasomotor Symptoms
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Actual): 1465

Contacts and Locations

• Study Contact: Name: Medical Affairs Europe; Phone Number: +44 (0) 20 3379 8000; Email: Astellas.registration@astellas.com

Study Locations

• United Kingdom
  • Hammersmith, United Kingdom
    • Site GB44001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

post-menopausal women with moderate to severe VMS associated with menopause

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
post-menopausal women; post-menopausal women with moderate to severe VMS associated with menopause	Other: No Intervention; This is a non-product related survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	1 day (once through survey)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day (once through survey)

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe Ltd.
• Investigators: Study Director: Senior Director, Astellas Pharma Europe Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Actual): August 27, 2023
• Study Completion (Actual): August 27, 2023

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: vasomotor symptoms; menopause
• Other Study ID Numbers: 2693-MA-3237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No