Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial
Primary result · Mean change from baseline in daily moderate to severe VMS frequencyResult — go to the resultLeast-squares mean difference −1.6 95% CI −2.0 to −1.1Authors' conclusion
The OASIS-3 randomized clinical trial expanded on findings from the 26-week OASIS-1 and OASIS-2 trials, exploring the use of elinzanetant over a longer duration and in a broader population. Elinzanetant shows promise as a treatment for moderate to severe VMS.
Study context
- Population
- Postmenopausal women aged 40 to 65 years seeking treatment for moderate to severe vasomotor symptoms (VMS) (no minimum number of VMS events per week), 83 sites in North America and Europe
- Participants
- 313 vs 315
- Comparison
- Once-daily oral elinzanetant 120 mg vs placebo for 52 weeks
- Elinzanetantn = 313
- Placebon = 315reference
- Primary endpoint
- Mean change from baseline in frequency of daily moderate to severe VMS (mixed model with repeated measures)
- Follow-up
- Week 12
Methodological detailsdouble-blind, placebo-controlled, phase 3, 83 sites, Conducted August 27, 2021, to February 12, 2024; data analysed March 11, 2024
- Double-blind
- Placebo-controlled
- Phase 3
- 83 sites
- Conducted August 27, 2021, to February 12, 2024; data analysed March 11, 2024
Primary result
As reported in the abstract
Least-squares mean difference
−1.6
95% CI −2.0 to −1.1
P < 0.001
Change by group
Elinzanetant
−5.4
mean · 95% CI −6.3–-4.5
Placebo
−3.5
mean · 95% CI −4.1–-2.9
Secondary outcomes
VMS frequency and severity over 50 weeks; sleep disturbances and menopause-related quality of life over 52 weeks
- Descriptive analyses showed numerical advantages for elinzanetant vs placebo
- No statistical hypotheses defined; not powered for between-group differences
Safety
Treatment-related adverse events
Treatment-related adverse events
- Most frequent: somnolence, fatigue, and headache
Hepatic, endometrial and bone safety
- Elinzanetant not associated with hepatotoxic effects, endometrial hyperplasia, or meaningful changes in bone density or bone turnover markers
Original publication
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