Esmirtazapine treatment of postmenopausal vasomotor symptoms: two randomized controlled trials
M Birkhaeuser, J Bitzer, S Braat, Y Ramos
CLIMACTERIC | TAYLOR & FRANCIS LTD | Published : 2019
OBJECTIVES: Two identical 12-week, randomized, double-blind, placebo-controlled, multi-arm, parallel-group Phase III studies (Study P012, NCT00560833; Study P013, NCT00535288) evaluated the efficacy and safety of esmirtazapine, an investigational medicine, for the treatment of moderate to severe vasomotor symptoms (VMS) in postmenopausal women. METHODS: Participants were randomized to placebo or esmirtazapine (2.25, 4.5, 9.0, or 18.0 mg). Co-primary efficacy endpoints (daily frequency and severity of moderate to severe VMS, both at weeks 4 and 12) were based on participative LogPad daily diaries. Adverse events (AEs) were recorded. RESULTS: In Studies P012 and P013, 942 and 946 participants ..View full abstract
Funding for this research was provided by Organon, a subsidiary of Akzo Nobel at the time of study conduct, and subsequently of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.