OASIS 1
Trial question
What is the role of elinzanetant in postmenopausal women with moderate-to-severe vasomotor symptoms?
Study design
Multi-center
Double blinded
RCT
Population
396 female patients.
Inclusion criteria: postmenopausal women aged 40-65 years experiencing moderate-to-severe vasomotor symptoms.
Key exclusion criteria: abnormal liver parameters; disordered proliferative endometrium; endometrial hyperplasia or polyps; current or history of malignancy within the past 5 years.
Interventions
N=199 elinzanetant (at a dose of 120 mg once daily for 26 weeks).
N=197 placebo (matching placebo for 12 weeks, followed by elinzanetant 120 mg once daily for 14 weeks).
Primary outcome
Mean reduction in frequency of moderate-to-severe vasomotor symptoms at week 4
7.5
4.4
7.5 episodes
5.6 episodes
3.8 episodes
1.9 episodes
0.0 episodes
Elinzanetant
Placebo
Significant
increase ▲
Significantly greater reduction in mean frequency of moderate-to-severe vasomotor symptoms at week 4 (7.5 episodes vs. 4.4 episodes; LSMD 3.3, 95% CI 2.1 to 4.5).
Secondary outcomes
Significantly greater reduction in frequency of moderate-to-severe vasomotor symptoms at week 12 (8.7 episodes vs. 5.5 episodes; LSMD 3.2, 95% CI 1.6 to 4.8).
Significantly lower reduction in severity of moderate-to severe-vasomotor symptoms at week 12 (0.95 points vs. 0.55 points; LSMD 0.4, 95% CI 0.3 to 0.5).
Significantly greater reduction in sleep disturbances at week 12 (10.8 points vs. 5 points; LSMD 5.6, 95% CI 4 to 7.2).
Safety outcomes
No significant difference in serious treatment-emergent adverse events.
Conclusion
In postmenopausal women aged 40-65 years experiencing moderate-to-severe vasomotor symptoms, elinzanetant was superior to placebo with respect to mean reduction in frequency of moderate-to-severe vasomotor symptoms at week 4.
Reference
JoAnn V Pinkerton, James A Simon, Hadine Joffe et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials. JAMA. 2024 Aug 22:e2414618. Online ahead of print.
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