Trial reportThe Journal of international medical research2024
Efficacy and safety of fezolinetant for moderate to severe vasomotor symptoms associated with menopause among women in East Asia: a phase 3 randomized study (MOONLIGHT I).
Trial report in The Journal of international medical research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed.
- Efficacy and safety of GS1-144, a novel neurokinin 3 receptor antagonist, for moderate-to-severe vasomotor symptoms associated with menopause in Chinese women: a randomized, double-blind, placebo-controlled phase 2 trial.Menopause (New York, N.Y.) · 2026Trial
- Long-term safety of fezolinetant in Chinese women with vasomotor symptoms associated with menopause: the phase 3 open-label MOONLIGHT 3 clinical trial.The Journal of international medical research · 2024Trial
- Flushing: Neuroendocrine Mechanisms and a Structured Diagnostic Approach.Clinical endocrinology · 2026Review
- Neurokinin pathway antagonists for vasomotor symptoms in women with breast cancer: focus on elinzanetant and fezolinetant.Breast (Edinburgh, Scotland) · 2026Review
- Risk factors, management and consequences of severe menopausal vasomotor symptoms.Nature reviews. Endocrinology · 2026Review
- Potential risk of neoplasms with fezolinetant: clinical evidence, mechanisms, and post-marketing implications.Journal of the Endocrine Society · 2026Review
- Management of menopausal hot flushes. Recommendations from the Spanish Menopause Society.European journal of obstetrics & gynecology and reproductive biology: X · 2025Review
- Reproductive aging in biological females: mechanisms and immediate consequences.Frontiers in endocrinology · 2025Review
- An Open-Label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects.Drug design, development and therapy · 2025Article
- Fezolinetant for moderate to severe vasomotor symptoms associated with menopause.Australian prescriber · 2024Review
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy and safety of fezolinetant for moderate to severe vasomotor symptoms (VMS) associated with menopause in East Asian women.
methodsIn this phase 3, randomized, double-blind study, postmenopausal women with moderate to severe VMS (minimum average frequency in the 10 days before randomization, ≥7/day or 50/week) received fezolinetant 30 mg/day or placebo (weeks 1-12), followed by an open-label extension phase with fezolinetant 30 mg/day (weeks 13-24). The co-primary endpoints were the mean changes in the daily frequency and severity of VMS at weeks 4 and 12.
resultsAmong 301 participants, the difference in the least squares mean change (95% confidence interval) from baseline in the daily frequency of moderate to severe VMS versus placebo was -0.65 (-1.41 to 0.12) at week 4 and -0.55 (-1.35 to 0.26) at week 12. The differences in the least squares mean change from baseline in the VMS severity score versus placebo were -0.06 (-0.14 to 0.03) and -0.13 (-0.27 to 0.01) at weeks 4 and 12, respectively. Serious adverse events occurred in 0.7% of participants receiving fezolinetant in weeks 1 to 12, compared with 1.3% of those receiving placebo.
conclusionsFezolinetant was generally safe but did not reduce the frequency or severity of VMS versus placebo in postmenopausal women in this study.
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