Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials
Authors' conclusion
Elinzanetant was well tolerated and efficacious for moderate to severe menopausal VMS.
Study context
- Population
- Postmenopausal women aged 40–65 years with moderate to severe vasomotor symptoms (VMS); OASIS 1: 77 sites in US, Europe, Israel; OASIS 2: 77 sites in US, Canada, Europe; mean age 54.6 years309 and 324 completed
- Comparison
- Elinzanetant 120 mg once daily vs placebo
- Elinzanetantn = OASIS 1: 199; OASIS 2: 200
- Placebon = OASIS 1: 197; OASIS 2: 200reference
- Primary endpoint
- Mean change in frequency and severity of moderate to severe VMS (electronic hot flash daily diary)
- Follow-up
- Baseline to weeks 4 and 12
Methodological detailstwo trials (OASIS 1 and 2), double-blind, placebo-controlled, phase 3, multicentre
- Two trials (OASIS 1 and 2)
- Double-blind
- Placebo-controlled
- Phase 3
- Multicentre
Primary result
As reported in the abstract
Change in VMS frequency and severity, elinzanetant vs placebo · weeks 4 and 12
Each group vs placeboEstimateP value
Elinzanetant
difference in VMS frequency, OASIS 1, week 4 −3.3(95% CI −4.5 to −2.1)
P < 0.001Elinzanetant
difference in VMS frequency, OASIS 2, week 4 −3.0(95% CI −4.4 to −1.7)
P < 0.001Elinzanetant
difference in VMS frequency, OASIS 1, week 12 −3.2(95% CI −4.8 to −1.6)
P < 0.001Elinzanetant
difference in VMS frequency, OASIS 2, week 12 −3.2(95% CI −4.6 to −1.9)
P < 0.001Elinzanetant
difference in VMS severity, OASIS 1, week 4 −0.3(95% CI −0.4 to −0.2)
P < 0.001Elinzanetant
difference in VMS severity, OASIS 2, week 4 −0.2(95 CI −0.3 to −0.1)
P < 0.001Elinzanetant
difference in VMS severity, OASIS 1, week 12 −0.4(95% CI −0.5 to −0.3)
P < 0.001Elinzanetant
difference in VMS severity, OASIS 2, week 12 −0.3(95% CI −0.4 to −0.1)
P < 0.001Secondary outcomes
| Outcome | Elinzanetant | Placebo |
|---|---|---|
| Baseline VMS frequency per 24 h, OASIS 1Mean | 13.4 (SD 6.6) | 14.3 (SD 13.9) |
| Baseline VMS frequency per 24 h, OASIS 2Mean | 14.7 (SD 11.1) | 16.2 (SD 11.2) |
| Baseline VMS severity, OASIS 1 | 2.6 (SD 0.2) | 2.5 (SD 0.2) |
| Baseline VMS severity, OASIS 2 | 2.5 (SD 0.2) | 2.5 (SD 0.2) |
Sleep disturbance (PROMIS SD-SF 8b) and menopause-specific QoL (MENQOL) · week 12
- Elinzanetant improved sleep disturbances and menopause-related quality of life at week 12
Safety
- The safety profile was favorable
Original publication
Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials. JAMA. Published 22 August 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →