OASIS 2
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
400 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=200 elinzanetant (at a dose of 120 mg once daily for 26 weeks).
N=200 placebo (matching placebo for 12 weeks, followed by elinzanetant 120 mg once daily for 14 weeks).
Primary outcome
Reduction in frequency of moderate-to-severe vasomotor symptoms at week 4
8.6
6.1
8.6 episodes
6.4 episodes
4.3 episodes
2.1 episodes
0.0 episodes
Elinzanetant
Placebo
Significant
increase ▲
Significantly greater reduction in frequency of moderate-to-severe vasomotor symptoms at week 4 (8.6 episodes vs. 6.1 episodes; LSMD 3, 95% CI 1.7 to 4.4).
Secondary outcomes
Significantly greater reduction in frequency of moderate-to-severe vasomotor symptoms at week 12 (10 episodes vs. 7.2 episodes; LSMD 3.2, 95% CI 1.9 to 4.6).
Significantly lower reduction in severity of moderate-to-severe vasomotor symptoms at week 12 (0.97 points vs. 0.65 points; LSMD 0.3, 95% CI 0.1 to 0.4).
Significantly greater reduction in sleep disturbances at week 12 (10.6 points vs. 5.5 points; LSMD 4.3, 95% CI 2.9 to 5.8).
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 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.
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