Dr Elizabeth Rayment1, Ms Christine Kemp2, Dr Marcos Freire3, Dr Farid Abdul Hadi3, Dr Daniel Bin Ng3, Dr Priscila Rocha4, Ms Emma Peffer4, Dr Natassia Rodrigo5
1Sydney Adventist Hospital, Wahroonga, Australia, 2Astellas Pharma Australia Pty Ltd, Macquarie Park, Australia, 3Astellas Pharma Pte Ltd, Singapore, Singapore, 4IQVIA Solutions Australia Pty Ltd, Sydney, Australia, 5Kolling Institute of Medical Research, St Leonards, Australia
Biography:
Christine Kemp B.Pharm, MPH is currently the Medical Affairs Co-Lead, Women’s Health at Astellas Pharma Australia Pty Ltd., where she has worked for the past 11 years across numerous therapeutic areas. Christine previously worked as a clinical pharmacist in paediatric and adult teaching hospitals before joining the pharmaceutical industry in 2006.
Abstract:
Aims:
Vasomotor symptoms (VMS) are associated with sleep disturbance, mood changes, and decreased quality-of-life. Most Australian women experiencing VMS do not receive treatment. Menopausal hormone therapy is the standard-of-care, but may not be appropriate for everyone. Fezolinetant is approved as a nonhormonal treatment option for moderate to severe VMS associated with menopause in many regions, including North America, Europe, Asia and Australia. To date, this is the first multicenter, single-arm, observational study to investigate sleep outcomes among women with VMS symptoms associated with menopause treated with fezolinetant in Australian real-world setting.
Methods:
Data will be collected from healthcare providers and patients. The primary objective is to assess the percentage of women (n>100, age≥40 years) reporting improvement in sleep disturbance at week 12 following fezolinetant treatment initiation. Secondary objectives assess VMS improvements, treatment patterns, reasons for treatment initiation and discontinuation, menopause-related quality-of-life, treatment satisfaction, and adverse events at weeks 12 and 24. Exploratory objectives assess outcomes at weeks 4 and 8, and evaluate change in anxiety symptoms at weeks 12 and 24.
Results:
Expected August 2026.
Conclusions:
ADELE-AU will provide valuable real-world evidence for fezolinetant treatment of moderate to severe VMS associated with menopause in the context of Australian clinical practice.