Overview

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The efficacy of LYNKUET^® for the treatment of moderate to severe VMS due to menopause was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials

Select inclusion criteria

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• Menopausal women aged 40-65 years
• ≥50 moderate to severe hot flashes, including night-time hot flashes, per week
• Postmenopausal status was defined as at least 12 months of spontaneous amenorrhea, or at least 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels >40 mIU/mL and a serum estradiol concentration of <30 pg/mL, or at least 6 months after hysterectomy with serum follicle-stimulating hormone >40 mIU/mL and serum estradiol <30 pg/mL, or at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy

Trial design

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A total of 796 menopausal women were randomized 1:1 to receive LYNKUET 120 mg or placebo once daily at bedtime for 12 weeks 

OASIS 1

• LYNKUET: N=199
• Placebo: N=197

OASIS 2

• LYNKUET: N=200
• Placebo: N=200

Co-primary endpoints

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Mean change in the frequency and severity of moderate to severe VMS from baseline to Weeks 4 and 12, including day and night hot flashes, measured using the Hot Flash Daily Diary (HFDD)

Select key secondary endpoints

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• Mean change in the frequency of moderate to severe VMS from baseline to Week 1 measured using the HFDD
• Mean change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance-Short Form 8b (PROMIS SD SF 8b) total T-score from baseline to Week 12