ResearchGeneral gynecologyDesvenlafaxine for the treatment of vasomotor symptoms associated with menopause: a double-blind, randomized, placebo-controlled trial of efficacy and safety
Section snippets
Materials and Methods
For this registration trial, methods, including inclusion criteria and primary outcome measures, were based on US Food and Drug Administration guidelines and European Medicines Agency guidance for VMS trials.18, 27
Results
From August 2004 through December 2004, 987 women were screened and 567 subjects were randomized in the study (Figure 1). Of those, 484 subjects (85.4%) completed at least 1 on-therapy evaluation for primary efficacy endpoints and were included in the ITT population. Overall, 393 of 484 subjects (81.2%) completed 12 weeks of therapy, and 368 of 484 subjects (76.0%) completed the 26-week study. More desvenlafaxine-treated subjects discontinued from the study compared with placebo (P = .009); the
Comment
The results of this randomized, double-blind, placebo-controlled trial indicate that desvenlafaxine is an effective therapy for moderate to severe VMS associated with menopause. The 100 and 150 mg desvenlafaxine doses significantly reduced the number and severity of HFs when compared with placebo after 4 and 12 weeks of treatment. Statistical separation over placebo was demonstrated as early as the first week of therapy.
Both desvenlafaxine doses achieved significant reductions in the number of
Acknowledgments
A list of the Study 319 investigators is included in an appendix. The authors thank Drs Kathleen Dorries and Mary Hanson for assistance in the preparation of the manuscript.
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Cited by (0)
This study was supported in part by Wyeth Research. Dr David Archer is a consultant for Wyeth Research and has received Grants and honoraria from the Wyeth Speakers Bureau. Dr Caroline DuPont participated in a Wyeth Consultant Board meeting in 2006. Drs Ginger Constantine, James Pickar, and Sophie Olivier are employed by Wyeth Research. The research described in this manuscript was supported by Wyeth Research.
Cite this article as: Archer DF, Dupont CM, Constantine GD, et al. Desvenlafaxine for the treatment of vasomotor symptoms associated with menopause: a double-blind, randomized, placebo-controlled trial of efficacy and safety. Am J Obstet Gynecol 2009;200:238.e1-238.e10.