In a Phase 3 Trial, Hormone Therapy Reduced Menopause Symptoms

Fezolinetant was found to reduce the frequency and intensity of moderate-to-severe vasomotor symptoms (VMS), or hot flashes, caused by menopause in a Phase 3 research.

The 52-week SKYLIGHT 2 study looked to explore if fezolinetant (a neurokinin 3 receptor antagonist) may lessen the prevalence and severity of moderate-to-severe VMS and sleep disturbance. The mean decrease in patient-reported sleep disruption from baseline to week 12 was a key secondary aim in the trial.

“VMS linked with menopause, which are characterized by hot flashes and/or night sweats, affect millions of women worldwide and can have an impact on daily activities and quality of life,” said University of North Carolina School of Medicine professor Genevieve Neal-Perry.

In a 12-week double-blind Phase 3 study, 501 postmenopausal women ages 40–65 having an average of seven or more moderate-to-severe hot flashes per day were given either placebo or one of two once-daily fezolinetant dosages—30mg or 45mg. During the extension phase, individuals on placebo were re-randomized to fezolinetant 30mg or 45mg, while those on fezolinetant were kept on their dose for the remaining 40 weeks. The study’s extension period included 484 women.

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When fezolinetant was compared to placebo at week 12, Neal-Perry and colleagues discovered that fezolinetant improved VMS frequency and intensity. Both doses were associated with a statistically significant reduction in the frequency and intensity of hot flashes, which lasted throughout the whole 52-week study. The findings support the safety and tolerability of fezolinetant at dosages of 30 and 45 mg.

The incidence and severity of VMS were reduced in women who were re-randomized from placebo to fezolinetant, equivalent to those who had been randomized to fezolinetant initially. The medication also reduced sleep interruptions, according to the Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS SD SF 8b).

“These findings, together with those from other fezolinetant trials, will help us better understand how to employ this nonhormonal selective NK3 receptor antagonist to treat moderate-to-severe VMS associated with menopause,” said Neal-Perry.

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