A Survey About Trade-offs When Choosing Menopause Treatments

NCT ID: NCT05300568

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1465 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-17
• Study Completion Date: 2023-08-27

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

post-menopausal women

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

No Intervention

Intervention Type: OTHER

This is a non-product related survey.

Interventions

No Intervention

This is a non-product related survey.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Europe Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Senior Director

Role: STUDY_DIRECTOR

Astellas Pharma Europe Ltd.

Locations

Site GB44001

Hammersmith, , United Kingdom

Countries

United Kingdom

Other Identifiers

2693-MA-3237

Identifier Type: -

Identifier Source: org_study_id