American Journal of Obstetrics & Gynecology
Volume 200, Issue 2 , Pages 172.e1-172.e10 , February 2009

A double-blind, randomly assigned, placebo-controlled study of desvenlafaxine efficacy and safety for the treatment of vasomotor symptoms associated with menopause

Presented at the 63rd Annual Meeting of the American Society for Reproductive Medicine, Washington, DC, Oct. 13-17, 2007, and the 2007 National Clinical Conference of the American College of Nurse Practitioners, San Antonio, TX, Oct. 24-28, 2007.

  • David F. Archer, MD

      Affiliations

    • Clinical Research Center, Eastern Virginia Medical School, Norfolk, VA
    • Corresponding Author InformationReprints: David F. Archer, MD, The Jones Institute for Reproductive Medicine, 601 Colley Ave., Norfolk, VA 23507
  • ,
  • Larry Seidman, DO

      Affiliations

    • Philadelphia Clinical Research, Philadelphia, PA
  • ,
  • Ginger D. Constantine, MD

      Affiliations

    • Wyeth Research, Collegeville, PA
  • ,
  • James H. Pickar, MD

      Affiliations

    • Wyeth Research, Collegeville, PA
  • ,
  • Sophie Olivier, MD

      Affiliations

    • Wyeth Research, Collegeville, PA

Received 2 May 2008 ,Revised 8 August 2008 ,Accepted 30 September 2008.

  • Image Result

    Participant flow chart

    a The total is > 100%; some women were excluded for multiple reasons; b The mITT population included all randomly assigned participants who took at least 1 dose of the study drug

    Participant flow chart

    a The total is > 100%; some women were excluded for multiple reasons; b The mITT population included all randomly assigned participants who took at least 1 dose of the study drug and had ≥ 5 days of vasomotor symptom data at baseline and ≥ 5 on-therapy days of vasomotor symptom data during the first 12 weeks.

    Archer. Desvenlafaxine efficacy and safety for vasomotor symptoms in menopause. Am J Obstet Gynecol 2009.

  • Image Result
    Decrease in number of moderate to severe hot flushes over 12 weeks, mITT population, last observation carried forwarda The significant decrease for both desvenlafaxine 100- and 150-mg/d groups compare

    Decrease in number of moderate to severe hot flushes over 12 weeks, mITT population, last observation carried forward

    a The significant decrease for both desvenlafaxine 100- and 150-mg/d groups compared with placebo. Error bars indicate standard error. The 100- and 150-mg/d desvenlafaxine groups had significantly greater decreases than the placebo group at all time points (all comparisons, P ≤ .012). mITT, modified intent to treat.

    Archer. Desvenlafaxine efficacy and safety for vasomotor symptoms in menopause. Am J Obstet Gynecol 2009.

  • Image Result
    Responder analysis, mITT population, last observation carried forwardA, Percentage of women with ≥ 50% decrease in average daily number of moderate to severe hot flushes. B, Percentage of women with ≥

    Responder analysis, mITT population, last observation carried forward

    A, Percentage of women with ≥ 50% decrease in average daily number of moderate to severe hot flushes. B, Percentage of women with ≥ 75% decrease in average daily number of moderate to severe hot flushes. The number of women who responded with a decrease of ≥ 50% and ≥ 75% in the average daily number of moderate and severe hot flushes was significantly greater in each desvenlafaxine treatment group than in the placebo group at weeks 4 and 12 (all comparisons, P < .001). a Significantly different from placebo. mITT, modified intent to treat.

    Archer. Desvenlafaxine efficacy and safety for vasomotor symptoms in menopause. Am J Obstet Gynecol 2009.

 Cite this article as: Archer DF, Seidman L, Constantine GD, et al. A double-blind, randomly assigned, placebo-controlled study of desvenlafaxine efficacy and safety for the treatment of vasomotor symptoms associated with menopause. Am J Obstet Gynecol 2009;200:172.e1-172.e10.

 This study was supported in part by Wyeth Research. Dr Archer is a consultant for Wyeth Research and has received grants and honoraria from the Wyeth Speakers Bureau. Dr Seidman is a consultant for Wyeth Research, Duramed Pharmaceuticals, Inc, and Bayer Pharmaceuticals Corp. Drs Constantine, Pickar, and Olivier are employees of Wyeth Research.

PII: S0002-9378(08)02001-2

doi: 10.1016/j.ajog.2008.09.877

American Journal of Obstetrics & Gynecology
Volume 200, Issue 2 , Pages 172.e1-172.e10 , February 2009