Natassia Rodrigo1, Elizabeth Rayment2, Christina Jang3, Shejil Kumar4, Kevin Lee5, Di Zhao6, Marcos Freire7, Alana Philips8, Farid Abdul Hadi7, Daniel Bin Ng7, Karla Martins9
1Kolling Institute of Medical Research, St Leonards, Australia, 2Sydney Adventist Hospital, Wahroonga, Australia, 3Royal Brisbane and Women's Hospital, Herston, Australia, 4Endocrinology Department, Royal North Shore Hospital, Sydney, Australia, 5Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia, 6Astellas Pharma Global Development Inc., Northbrook, United States of America, 7Astellas Pharma Pty Ltd, Singapore, Singapore, 8Astellas Pharma Australia Pty Ltd., Macquarie Park, Australia, 9Astellas Pharma Europe Ltd, Addlestone, United Kingdom
Biography:
Dr. Rodrigo is a Staff Specialist in Diabetes and Endocrinology at Nepean Hospital, Kingswood, and at the Royal North Shore Hospital, Sydney.
Aims:
Vasomotor symptoms (VMS) are associated with sleep disturbance, mood changes, and decreased quality of life (QoL). Fezolinetant is an oral, once-daily, non-hormonal neurokinin-3 receptor antagonist approved for treatment of moderate to severe VMS associated with menopause. This preliminary analysis of ADELE-AU evaluates real-world sleep outcomes in fezolinetant-treated Australian women.
Methods:
ADELE‑AU is an observational, longitudinal, prospective, multicenter, single-arm study of women aged ≥40 years initiating fezolinetant for moderate to severe VMS with sleep disturbances. Primary objective: percentage reporting improvement in sleep disturbance (PGI-C SD) at week 12. Secondary: VMS/sleep improvements, treatment patterns/satisfaction/discontinuation, menopause-related QoL, and adverse events (AEs) at week 12. Exploratory: weeks 4/8 outcomes.
Results:
As of March 2026, 16 participants enrolled (target n=50): mean (SD) age and BMI: 54.5 (8.2) years, 30.4 (5.4) kg/m², respectively; n=6 (37.5%) perimenopausal, n=10 (62.5%) postmenopausal. 10/13 (77%) reported sleep disturbance improvement: “moderately better”/ “much better” on PGI-C SD following 12 weeks of fezolinetant treatment (primary). Improvement was observed across validated patient-reported outcomes at weeks 12 (secondary) and 4/8 (exploratory). Fezolinetant was well-tolerated; no liver-related AEs reported.
Conclusions:
Preliminary ADELE-AU results support real-world benefits of fezolinetant on sleep disturbance among women with moderate to severe VMS associated with menopause, consistent with clinical studies.