A Survey About Trade-offs When Choosing Menopause Treatments

NCT05300568 | Completed

• 1 other identifier: 2693-MA-3237
• Study Type: observational
• Target: 1,465
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate to Severe Vasomotor Symptoms

Keywords

menopause; vasomotor symptoms

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Estimated probability that a specific treatment profile will be chosen

  1 day (once through survey)

Study Arms (1)

post-menopausal women

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

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-product related survey.

post-menopausal women

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Europe Ltd.: lead

Study Sites (1)

Site GB44001

Hammersmith, United Kingdom

Location

Study Officials

• Senior Director

  Astellas Pharma Europe Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 29, 2022
• Study Start: August 17, 2022
• Primary Completion: August 27, 2023
• Study Completion: August 27, 2023
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)