Clinical trial NCT05083884: A Survey About Hot Flashes in Women Going Through the Menopause
Official title: Prospective Survey of Women With Vasomotor Symptoms Associated With Menopause in Nordic Europe, Canada, Brazil and Mexico - WARM Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Vasomotor Symptoms
Keywords: Menopause
Vasomotor Symptoms
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 2176
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peri- and post-menopausal women with moderate to severe VMS symptoms

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of moderate to severe vasomotor symptoms (VMS) in post-menopausal women
timeFrame: 1 day (once through survey)
Secondary outcomes:
measure: Health Related Quality of Life (HRQoL) measured by the Menopause Specific QoL Questionnaire (MENQoL)
timeFrame: 1 day (once through survey)
measure: Health Related Quality of Life (HRQoL) measured by Work Productivity and Activity Impairment-VMS (WPAI-VMS) Questionnaire
timeFrame: 1 day (once through survey)
measure: Health Related Quality of Life (HRQoL) measured by Patient-Reported Outcomes Measurement Information System - Sleep Disturbance (PROMIS)
timeFrame: 1 day (once through survey)
measure: Proportion of Participants with VMS seeking healthcare professionals' (HCP) advice
timeFrame: 1 day (once through survey)
measure: Proportion of Participants with VMS taking over the counter treatment for moderate to severe VMS symptoms
timeFrame: 1 day (once through survey)
measure: Proportion of Participants incurring average out-of-pocket expenses incurred in treatment of menopause
timeFrame: 1 day (once through survey)
measure: Percentage of peri-and post-menopausal women who seek help from HCPs for their menopause related symptoms (MR-VMS)
timeFrame: 1 day (once through survey)
measure: Health Related Quality of Life (HRQoL) measured by participants' attitudes to their VMS
timeFrame: 1 day (once through survey)
measure: Treatment patterns of peri- and post-menopausal women assessed by type of treatment
timeFrame: 1 day (once through survey)
measure: Treatment patterns of peri- and post-menopausal assessed by length of time on hormonal treatment
timeFrame: 1 day (once through survey)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: IQVIA
Study officials:
affiliation: Medical Affairs Europe
name: Medical Director
role: STUDY_DIRECTOR
References: