OASIS 1 and 2: Study Design and Key Efficacy Data

In this segment, Genevieve Neal-Perry, MD, PhD, describes the placebo-controlled, double-blind design of the OASIS 1 and OASIS 2 trials, which assessed elinzanetant (Lynkuet) for the treatment of moderate to severe VMS. The primary outcomes were reductions in hot flash frequency and severity over the first 12 weeks, followed by a crossover phase in which participants initially assigned to placebo received active treatment. Women enrolled in these studies reported a high symptom burden, averaging more than 13 hot flashes per day with moderate-to-severe intensity.

Neal-Perry explains that both trials enrolled a racially diverse population, including a substantial proportion of African American women. Pooled analyses demonstrated significant reductions in both frequency and severity of VMS with elinzanetant compared with placebo. Importantly, African American women, who entered the studies with higher baseline symptom burden, experienced improvements that brought symptom levels in line with those of non–African American participants.

Beyond VMS, the trials incorporated validated patient-reported outcome instruments, including PROMIS Sleep Disturbance Short Form and the Menopause-Specific Quality of Life (MENQOL) questionnaire. Neal-Perry notes that improvements in VMS translated into better sleep and overall quality of life, supporting the consistency of elinzanetant’s therapeutic effect across racial subgroups and reinforcing its potential to reduce longstanding disparities in menopause symptom management.