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For the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1

Data Over Time

OASIS 3 trial data
2

REVIEW STUDY DESIGN

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 hypothesis 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 met.4
SEE SAFETY DATA
Frequency & Severity
PROMIS SD SF 8b Data