The primary objective of this study is to determine the efficacy of both low-dose oral 17-ß-estradiol and the non-hormonal pharmacologic therapy venlafaxine XR relative to placebo in reducing hot flashes. Included in this objective is our intention to compare venlafaxine XR to estradiol therapy, to provide evidence of the relative efficacy of venlafaxine to what is currently
considered the most established but also controversial therapy. This is a randomized, doubleblind, placebo-controlled, three arm clinical trial. The design includes: 3 weeks of daily recording
of hot flashes prior to drug treatment; 8 weeks of double-blind treatment with oral estradiol, venlafaxine, or placebo; followed by 14 days of drug taper for those on venlafaxine and 14 days of progesterone treatment for those on estradiol; followed by 2 weeks with no treatment for all groups; and a telephone follow-up post-treatment.
The research team is studying two medicines that may help to reduce hot flashes. One is a low dose estrogen pill; the other is a serotonin-based pill called venlafaxine (brand name Effexor XR). The researchers want to know if women who take these medicines have fewer or less severe hot flashes than women who take a placebo (inactive pill). They also want to determine if one medicine is more effective than the other. A total of 304 women will be participating in this study across the United States at three research sites: Massachusetts General Hospital and Brigham and Women’s Hospital/Harvard Medical School, Boston; Group Health Research Institute, in Seattle; and University of Pennsylvania, Department of Obstetrics/Gynecology, Philadelphia. The Call to Action for this study was sent to Army of Women members on March 28, 2012. When the researchers closed enrollment on May 15, 2012, the Army of Women had provided them with 117 women who were interested in enrolling in the study.