Clinical Research Directory

A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause

Sponsor: Astellas Pharma Europe Ltd.

Summary

This study is for women in Germany who are going through menopause. They have symptoms including hot flashes and night sweats (also called vasomotor symptoms). Their doctor has decided to give them fezolinetant tablets to help treat these symptoms. Fezolinetant tablets do not contain hormones. Fezolinetant tablets have been approved in some countries to treat hot flashes and night sweats. Doctors have standard clinical practice guidelines to help them decide how to treat women who are going through menopause and have hot flashes and night sweats. The goal of this study is to learn about the value of fezolinetant tablets in treating hot flashes and night sweats that women in Germany experience during menopause. The women that want to take part in the study will take fezolinetant tablets for their hot flashes and night sweats. This study is about collecting information only. The individual's doctor decides on treatment, not the study sponsor (Astellas). The study will last about 6 months (24 weeks). During the study, the women taking part will complete up to 5 virtual reviews. The virtual reviews will ask the women to complete 3 - 5 surveys. At the first virtual review the women will be asked about their health and other medicines they have taken or are taking. The surveys will ask the women about their hot flashes and night sweats, other menopause symptoms, and how these symptoms affect their health and daily life. After the first or second virtual review the women will take their first dose of fezolinetant tablets and continue taking fezolinetant as explained by their doctor. The women will have 3 virtual follow-up reviews at about 1 week, 3 months (12 weeks), and 6 months (24 weeks) after their first dose of fezolinetant tablets. The women will be asked when they took their fezolinetant tablets or if they stopped taking them.

Official title: Fezolinetant Experience for the Treatment of Vasomotor Symptoms Associated With Menopause Among Women in a German Real-life Setting

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