A Survey About Hot Flashes in Women Going Through the Menopause

NCT ID: NCT05083884

Last Updated: 2024-10-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

2176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-04

Study Completion Date

2022-01-17

Brief Summary

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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.

Detailed Description

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Conditions

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Menopause Vasomotor Symptoms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1: Peri-menopausal woman

Grouping is based on Peri-menopausal woman

No Intervention

Intervention Type 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 2: Post- menopausal woman

Grouping is based on Post-menopausal woman

No Intervention

Intervention Type 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 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

Intervention Type 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 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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- 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

Exclusion Criteria

* 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.

Additional exclusion criterion for secondary outcome measures will be:

\- Mild VMS symptoms only
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Medical Affairs Europe

Locations

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IQVIA

London, , United Kingdom

Site Status

Countries

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United Kingdom

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.

Reference Type DERIVED
PMID: 37847872 (View on PubMed)

Related Links

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https://www.clinicaltrials.astellas.com/study/2693-MA-3235/

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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