A Survey About Hot Flashes in Women Going Through the Menopause

Astellas

Status: Completed

Conditions: Menopause; Vasomotor Symptoms

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05083884

2693-MA-3235

Details and patient eligibility

About

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.

Enrollment: 2,176 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

2,176 participants in 4 patient groups

Group 1: Peri-menopausal woman

Description:

Grouping is based on Peri-menopausal woman

Treatment:

Other: No Intervention

Group 2: Post- menopausal woman

Description:

Grouping is based on Post-menopausal woman

Treatment:

Other: No Intervention

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

Description:

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

Treatment:

Other: No Intervention

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

Description:

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

Treatment:

Other: No Intervention