A Survey About Trade-offs When Choosing Menopause Treatments

What this trial studies

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.

Conditions in scope

• Moderate to Severe Vasomotor Symptoms

Interventions

• No Intervention (Other) — This is a non-product related survey.

Who can join

Women only · Ages 40 Years to 65 Years

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Observational
• Phase: N/A
• Start date: 2022-08-17
• Primary completion: 2023-08-27
• Last update posted: 2024-10-26
• First posted: 2022-03-29

Sponsor & contact

Lead sponsor: Astellas Pharma Europe Ltd. (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Part-worth utilities for each treatment attribute (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 (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 (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 (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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.