A Survey About Hot Flashes in Women Going Through the Menopause
NCT ID: NCT05083884
Last Updated: 2024-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2176 participants
OBSERVATIONAL
2021-11-04
2022-01-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Group 1: Peri-menopausal woman
Grouping is based on Peri-menopausal woman
No Intervention
This is a cross-sectional non-product related survey including peri- and post-menopausal women with moderate to severe VMS associated with menopause.
Group 2: Post- menopausal woman
Grouping is based on Post-menopausal woman
No Intervention
This is a cross-sectional non-product related survey including peri- and post-menopausal women with moderate to severe VMS associated with menopause.
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)
No Intervention
This is a cross-sectional non-product related survey including peri- and post-menopausal women with moderate to severe VMS associated with menopause.
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)
No Intervention
This is a cross-sectional non-product related survey including peri- and post-menopausal women with moderate to severe VMS associated with menopause.
Interventions
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No Intervention
This is a cross-sectional non-product related survey including peri- and post-menopausal women with moderate to severe VMS associated with menopause.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Women treated with anti-estrogens, aromatase inhibitors or Gonadotropin-releasing hormone (GnRH) agonists/antagonists for cancer or any other medical condition.
Additional exclusion criterion for secondary outcome measures will be:
\- Mild VMS symptoms only
40 Years
65 Years
FEMALE
No
Sponsors
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Astellas Pharma Europe Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Medical Affairs Europe
Locations
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IQVIA
London, , United Kingdom
Countries
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References
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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.
Related Links
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Link to results and other applicable study documents on the Astellas Clinical Trials website
Other Identifiers
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2693-MA-3235
Identifier Type: -
Identifier Source: org_study_id
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