Long-term safety of fezolinetant in Chinese women with vasomotor symptoms associated with menopause: the phase 3 open-label MOONLIGHT 3 clinical trial
| Title: | Long-term safety of fezolinetant in Chinese women with vasomotor symptoms associated with menopause: the phase 3 open-label MOONLIGHT 3 clinical trial |
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| Authors: | Qi Yu, Fang Ming, Jiezhi Ma, Yiling Cai, Liping Wang, Mulan Ren, Jun Zhang, Xiao Ma, Kentaro Miyazaki, Weizhong He, Xuegong Wang |
| Source: | Journal of International Medical Research, Vol 52 (2024) |
| Publisher Information: | SAGE Publishing, 2024. |
| Publication Year: | 2024 |
| Collection: | LCC:Medicine (General) |
| Subject Terms: | Medicine (General), R5-920 |
| More Details: | Objective We aimed to assess long-term safety and tolerability of fezolinetant, a nonhormonal neurokinin 3 receptor antagonist, among Chinese women with vasomotor symptoms associated with menopause participating in the MOONLIGHT 3 trial. Methods In this phase 3 open-label study, women in menopause aged 40–65 years received fezolinetant 30 mg once daily for 52 weeks. The primary endpoint was frequency and severity of treatment-emergent adverse events (TEAEs), assessed at every visit through week 52 and one follow-up visit at week 55. Results Overall, 150 women were enrolled (mean age, 54 years) and 105 completed treatment. The frequency of TEAEs was 88.7%. Most TEAEs were mild (63.3%) or moderate (22.7%). The most common TEAE was upper respiratory tract infection (16.0%), followed by dizziness, headache, and protein urine present (10.7% each). There was no clinically relevant change (mean ± standard deviation) in endometrial thickness (baseline, 2.95 ± 1.11 mm; week 52, 2.94 ± 1.18 mm). Alanine aminotransferase and/or aspartate aminotransferase levels >3 times the upper limit of normal were reported in 1.4% of women; no Hy’s Law cases occurred. Conclusions Fezolinetant 30 mg once daily was generally safe and well tolerated over a 52-week period among women in China with vasomotor symptoms associated with menopause. ClinicalTrials.gov Identifier: NCT04451226 |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 1473-2300 03000605 |
| Relation: | https://doaj.org/toc/1473-2300 |
| DOI: | 10.1177/03000605241246624 |
| Access URL: | https://doaj.org/article/94aa3a2e936a47c88edf767114c25d12 |
| Accession Number: | edsdoj.94aa3a2e936a47c88edf767114c25d12 |
| Database: | Directory of Open Access Journals |
| ISSN: | 14732300 03000605 |
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| DOI: | 10.1177/03000605241246624 |
| Published in: | Journal of International Medical Research |
| Language: | English |