A Survey About Hot Flashes in Women Going Through the Menopause

Menopause Clinical Trial

Official title:

Prospective Survey of Women With Vasomotor Symptoms Associated With Menopause in Nordic Europe, Canada, Brazil and Mexico - WARM Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05083884
• Other study ID #: 2693-MA-3235
• Status: Completed
• Start date: November 4, 2021
• Est. completion date: January 17, 2022

Study information

• Verified date: March 2023
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2176
• Est. completion date: January 17, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria (primary outcome measure):

• Post-menopausal women

Inclusion Criteria (secondary outcome measure):

• 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 (primary outcome measure):

• 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

Related Conditions & MeSH terms

• Menopause
• Vasomotor Symptoms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	IQVIA	London

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Health Related Quality of Life (HRQoL) measured by the Menopause Specific QoL Questionnaire (MENQoL)	MENQoL measures the overall score and four domain-specific scores assessing wellbeing (vasomotor; psychosocial; physical; sexual). Scores range from 1 to 8 with a higher score indicating worsening/increasing bothersomeness by the symptom experience. The MENQoL recall period is 7 days prior to survey.	1 day (once through survey)
Secondary	Health Related Quality of Life (HRQoL) measured by Work Productivity and Activity Impairment-VMS (WPAI-VMS) Questionnaire	The WPAI-VMS questionnaire measures four domain specific scores assessing work productivity and activity impairment over the previous week (absenteeism; presenteeism; mean work productivity; activity impairment). Scores range from 0 to 100%. The four scores were expressed as impairment percentages with a higher score indicating less productivity and greater activity impairment. The WPAI recall period is 7 days prior to survey.	1 day (once through survey)
Secondary	Health Related Quality of Life (HRQoL) measured by Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS)	The PROMIS Sleep Disturbance instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. Each item on the measure is rated on a 5-point scale with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance. The PROMIS recall period is 7 days prior to survey.; (Only implemented in Canada, Brazil and Denmark).	1 day (once through survey)
Secondary	Proportion of Participants with VMS seeking healthcare professionals' (HCP) advice	The type of specialists reported by peri- and post-menopausal women will be assessed.	1 day (once through survey)
Secondary	Proportion of Participants with VMS taking over the counter treatment for moderate to severe VMS symptoms	The types of over the counter treatment taken by peri- and post-menopausal women for MR symptoms will be assessed.	1 day (once through survey)
Secondary	Proportion of Participants incurring average out-of-pocket expenses incurred in treatment of menopause	Average out-of-pocket expenses incurred in the treatment of menopause reported by medications bought will be assessed.	1 day (once through survey)
Secondary	Percentage of peri-and post-menopausal women who seek help from HCPs for their menopause related symptoms (MR-VMS)	Percentage of peri- and post-menopausal women who seek help from Health Care Professionals (HCPs) for their MR-VMS. Help from an HCP can be in the form of advice or receipt of pharmaceutical treatment.	1 day (once through survey)
Secondary	Health Related Quality of Life (HRQoL) measured by participants' attitudes to their VMS	Participants' attitudes towards their VMS will be evaluated using the following: agreement or disagreement to statements on menopause itself, available treatments, and willingness/aversion to hormone replacement therapy (HRT).	1 day (once through survey)
Secondary	Treatment patterns of peri- and post-menopausal women assessed by type of treatment	The number of peri- and post-menopausal women treated with hormonal treatment, non-hormonal treatment, or other approaches will be summarized.	1 day (once through survey)
Secondary	Treatment patterns of peri- and post-menopausal assessed by length of time on hormonal treatment	The length of time on hormonal treatment in peri- and post-menopausal women will be summarized.	1 day (once through survey)

External Links

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