Data Over Time
OASIS 3 trial data2
OASIS 3 was a randomized, double-blind, placebo-controlled, multicenter Phase 3 long-term safety trial up to 52 weeks, in postmenopausal women aged 40–65 years with moderate to severe VMS (no baseline requirements for a minimum number of moderate to severe VMS events per week).2
Primary endpoint: Mean change in the frequency of moderate to severe VMS, including day and night hot flashes, from baseline to Week 122
Disclaimers:
Changes over time, excluding Week 12, were based on descriptive analysis only. No statistical hypotheses were defined, nor was the study powered to detect between-group differences
A clinically meaningful reduction threshold of ≥2 hot flashes over 24 hours compared to placebo was not met4