A Survey About Hot Flashes in Women Going Through the Menopause

NCT05083884 | Completed

• 1 other identifier: 2693-MA-3235
• Study Type: observational
• Target: 2,176
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an online survey of women in and around menopause with moderate to severe hot flashes. Menopause, a normal part of life, is a 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 about how many women have moderate to severe hot flashes in menopause. It will also provide details on women's experiences with hot flashes. Women from Brazil, Canada, Nordic Europe, and Mexico will take part in this study. The women in this study will already be taking part in consumer panels. Women will be contacted based on their age. They will be asked if they would like to take part in this study. Firstly, the women will answer questions about whether they are in menopause or are getting close to menopause. They will also be asked how severe their hot flashes are. From their answers, some women will be asked to complete an online survey. These will be women who are in menopause and have moderate to severe hot flashes. They will provide more details about how hot flashes have impacted their lives. Also, they will answer questions on how hot flashes affect their quality of life. Finally, they will answer questions about their experiences when they visited their doctor about their hot flashes.

Conditions

Menopause; Vasomotor Symptoms

Keywords

Menopause; Vasomotor Symptoms

Outcome Measures

Primary Outcomes (1)

• Prevalence of moderate to severe vasomotor symptoms (VMS) in post-menopausal women

  Prevalence of moderate to severe VMS in post-menopausal women. Post-menopause is defined as at least 12 consecutive months without a period. Moderate VMS associated with menopause symptoms is defined as sensations of heat with sweating but being able to continue activities. Severe VMS associated with menopause is defined as feelings of intense heat with sweating causing cessation of activities. The recall period is 1 month prior to survey.

  1 day (once through survey)

Secondary Outcomes (10)

• Health Related Quality of Life (HRQoL) measured by the Menopause Specific QoL Questionnaire (MENQoL)

  1 day (once through survey)

• Health Related Quality of Life (HRQoL) measured by Work Productivity and Activity Impairment-VMS (WPAI-VMS) Questionnaire

  1 day (once through survey)

• Health Related Quality of Life (HRQoL) measured by Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS)

  1 day (once through survey)

• Proportion of Participants with VMS seeking healthcare professionals' (HCP) advice

  1 day (once through survey)

• Proportion of Participants with VMS taking over the counter treatment for moderate to severe VMS symptoms

  1 day (once through survey)

Study Arms (4)

Group 1: Peri-menopausal woman

Grouping is based on Peri-menopausal woman

Other: No Intervention

Group 2: Post- menopausal woman

Grouping is based on Post-menopausal woman

Other: No Intervention

Group 3: Peri-menopausal woman: moderate-to-severe MR-VMS

Grouping is based on Peri-menopausal woman with moderate-to-severe vasomotor symptoms (MR-VMS)

Other: No Intervention

Group 4: Post-menopausal woman: moderate-to-severe MR-VMS

Grouping is based on Post-menopausal woman with moderate-to-severe vasomotor symptoms (MR-VMS)

Other: No Intervention

Interventions

No Intervention OTHER

This is a cross-sectional non-product related survey including peri- and post-menopausal women with moderate to severe VMS associated with menopause.

Group 1: Peri-menopausal woman; Group 2: Post- menopausal woman; Group 3: Peri-menopausal woman: moderate-to-severe MR-VMS; Group 4: Post-menopausal woman: moderate-to-severe MR-VMS

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

Peri- and post-menopausal women with moderate to severe VMS symptoms

You may qualify if:

• \- Post-menopausal women
• Women currently experiencing, or have experienced in the last month, moderate to severe VMS symptoms (i.e. minimum of 1 moderate to severe hot flushes per day over the last month)
• Peri-menopausal and post-menopausal women

You may not qualify if:

• Women with current breast cancer treatment
• Women treated with anti-estrogens, aromatase inhibitors or Gonadotropin-releasing hormone (GnRH) agonists/antagonists for cancer or any other medical condition.
• \- Mild VMS symptoms only

Sponsors & Collaborators

• Astellas Pharma Europe Ltd.: lead

Study Sites (1)

IQVIA

London, N1 8JY, United Kingdom

Location

Related Publications (1)

• Todorova L, Bonassi R, Guerrero Carreno FJ, Hirschberg AL, Yuksel N, Rea C, Scrine L, Kim JS. Prevalence and impact of vasomotor symptoms due to menopause among women in Brazil, Canada, Mexico, and Nordic Europe: a cross-sectional survey. Menopause. 2023 Dec 1;30(12):1179-1189. doi: 10.1097/GME.0000000000002265. Epub 2023 Oct 19.

  PMID: 37847872 DERIVED

Related Links

• Link to results and other applicable study documents on the Astellas Clinical Trials website

Study Officials

• Medical Director

  Medical Affairs Europe

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 19, 2021
• Study Start: November 4, 2021
• Primary Completion: January 17, 2022
• Study Completion: January 17, 2022
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)