Study Evaluating The Safety And Efficacy Of Desvenlafaxine Succinate For Vasomotor Symptoms In Menopausal Women

• Drug: desvenlafaxine succinate (DVS) SR
  
  Titration with 50 mg tablets once daily for 7 days, then 100mg tablets once daily from day 8 to day 365, then taper with 50 mg tablets once daily for 7 days, followed by 25 mg tablets once daily for 7 days.
• Drug: Placebo
  
  Titration with 50 mg placebo tablets once daily for 7 days, then 100mg placebo tablets once daily from day 8 to day 365, then taper with 50 mg placebo tablets once daily for 7 days, followed by 25 mg placebo tablets once daily for 7 days.

• Experimental: 1
  
  desvenlafaxine succinate (DVS) SR
  Intervention: Drug: desvenlafaxine succinate (DVS) SR
• Placebo Comparator: 2
  
  Placebo
  Intervention: Drug: Placebo

• Archer DF, Pinkerton JV, Guico-Pabia CJ, Hwang E, Cheng RF; Study 3353 Investigators. Cardiovascular, cerebrovascular, and hepatic safety of desvenlafaxine for 1 year in women with vasomotor symptoms associated with menopause. Menopause. 2013 Jan;20(1):47-56. doi: 10.1097/gme.0b013e3182775fe9.
• Pinkerton JV, Archer DF, Guico-Pabia CJ, Hwang E, Cheng RF. Maintenance of the efficacy of desvenlafaxine in menopausal vasomotor symptoms: a 1-year randomized controlled trial. Menopause. 2013 Jan;20(1):38-46. doi: 10.1097/GME.0b013e318274699f.
• Pinkerton JV, Constantine G, Hwang E, Cheng RF; Study 3353 Investigators. Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial. Menopause. 2013 Jan;20(1):28-37. doi: 10.1097/gme.0b013e31826421a8.

Inclusion Criteria:

• Generally healthy, postmenopausal women who seek treatment for hot flushes
• Body Mass Index (BMI) less than or equal to 34 kg/m^2

Exclusion Criteria:

• Hypersensitivity to Venlafaxine
• Myocardial infarction an/or unstable angina within 6 months of screening
• History of seizure disorder