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Clinical Trial
. 2024 May;52(5):3000605241247684.
doi: 10.1177/03000605241247684.

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)

Xiangyan Ruan  1 , Wenpei Bai  2 , Mulan Ren  3 , Tak Kim  4 , Ji Young Lee  5 , Fei-Chi Chuang  6 , Peng-Hui Wang  7 , Weizhong He  8 , Xiao Ma  9 , Kentaro Miyazaki  10 , Nan Song  9 , Xuegong Wang  8 , Qi Yu  11
Affiliations
Clinical Trial

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)

Xiangyan Ruan et al. J Int Med Res. 2024 May.

Abstract

Objective: To evaluate the efficacy and safety of fezolinetant for moderate to severe vasomotor symptoms (VMS) associated with menopause in East Asian women.

Methods: In 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.

Results: Among 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.

Conclusions: Fezolinetant was generally safe but did not reduce the frequency or severity of VMS versus placebo in postmenopausal women in this study.ClinicalTrials.Gov Identifier: NCT04234204.

Keywords: Asia; Eastern; Fezolinetant, vasomotor symptoms, hot flashes, receptors; menopause; neurokinin 3; nonhormonal therapy.

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Conflict of interest statement

Declaration of conflicting interestsWeizhong He was an employee of Astellas Pharma Global Development, Inc., at the time of the study. Kentaro Miyazaki is an employee of Astellas Pharma, Inc., Xuegong Wang is an employee of Astellas Pharma Global Development, Inc., and Xiao Ma and Nan Song are employees of Astellas (China) Investment Co, Ltd. The remaining authors have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
Study design. Wk, week.
Figure 2.
Figure 2.
Participant flow.
Figure 3.
Figure 3.
Co-primary endpoints: Reduction from baseline in the frequency and severity of moderate to severe VMS at weeks 4 and 12 (full analysis set). (a) Frequency of VMS at weeks 4 and 12 and (b) Severity of VMS at weeks 4 and 12. CI, confidence interval; LS, least squares; VMS, vasomotor symptoms.
Figure 4.
Figure 4.
Percentage reduction from baseline in the VMS frequency by week during the 12-week randomized period (full analysis set). CI, confidence interval; LS, least squares; VMS, vasomotor symptoms; Wk, week.
Figure 5.
Figure 5.
Proportion of women with reductions from baseline in the frequency of moderate to severe VMS by week during the 12-week randomized period (full analysis set). (a) ≥50% reduction and (b) 100% reduction. CI, confidence interval; NC, not calculated; VMS, vasomotor symptoms; Wk, week.
Figure 6.
Figure 6.
Mean frequency per day and severity of moderate to severe VMS by visit during the 12-week randomized period and 12-week extension period (full analysis set). (a) Mean frequency and (b) Mean severity. SE, standard error; VMS, vasomotor symptoms.
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