Trial in Progress: Fezolinetant for VMS in a German Real-life Setting (GRACE)
Klaas Heinemann,1 Regina Schaetzle,2 Martin Blogg,3 Leigh Carter,3 Linda King,4 Stephen Jackson,3 Karla Martins3*
1ZEG -Berlin Center for Epidemiologyand HealthResearch, GmbH, Berlin, Germany; 2Astellas Pharma GmbH, Germany; 3Astellas Pharma Europe Ltd, UK; 4Astellas Pharma Inc, USA

 

Objective

To generate real-world evidence outcomes of fezolinetant 45 mg treatment for vasomotor symptoms (VMS) associated with menopause, including menopause-related quality of life; sleep; and safety, in the context of the German healthcare system

 

Introduction

The most common and bothersome symptoms associated with menopause are VMS, characterized by hot flushes and/or night sweats
•VMS negatively impact quality-of-life, sleep, mood, and work productivity1-4
•Hormone therapy is an effective treatment option but is not suitable for all women5
•Fezolinetant is a first-in-class, oral, nonhormonal, neurokinin 3 receptor antagonist that modulates neuronal activity in the thermoregulatory center in the hypothalamus. This inhibition leads to reductions in the frequency and severity of VMS associated with menopause6-8
•Fezolinetant is approved as a treatment option for moderate to severe VMS in many regions, including North America, Europe, Asia, and Australia, at a dose of 45 mg once daily7-12