Cancer Prevention Program
The long-term objective is to accelerate progress in identifying effective remedies for vasomotor symptoms (VMS) in women going through the menopausal transition. The Data Coordinating Center (DCC) will provide and coordinate all necessary leadership activities to facilitate collaboration and productivity in this group during all phases in the lifecycle of VMS clinical trials from hypothesis formulation to publication, dissemination, and data sharing. In conjunction with the network entitled, "The Menopausal Symptoms Initiative-Finding Lasting Answers to Sweats and Hot Flashes (MSI-FLASH)", five randomized controlled trials testing a range of behavioral, mind-body, hormonal and pharmacologic interventions to treat hot flashes are proposed (yoga and ultra low-dose E2 gel). To study these effects a factorial design RCT is planned which will also allow evaluation of the additive effect of these interventions, that is, whether the two combined are superior to either alone. The primary aims of this randomized controlled trial are to: 1) evaluate the effects of yoga vs. no yoga on: a) subjective VMS frequency ; and b) VMS bothersomeness; and 2) evaluate the effects of ultra-low dose E2 gel vs. placebo gel on: a) subjective VMS frequency; and b) VMS bothersomeness. It is also proposed to recruit participants for three other randomized trials for this network application; an SSRI trial, a slow deep breathing trial, and an exercise intervention trial.