Minimum trial duration to reasonably assess long-term efficacy of nonhormonal hot flash therapies.

@article{Guttuso2010MinimumTD,
  title={Minimum trial duration to reasonably assess long-term efficacy of nonhormonal hot flash therapies.},
  author={T Guttuso and Mich{\`e}le Evans},
  journal={Journal of women's health},
  year={2010},
  volume={19 4},
  pages={699-702}
}
BACKGROUND Because hot flashes usually persist for years after menopause, a clinically meaningful hot flash therapy needs to have long-term efficacy; however, it is unclear for how long a therapy needs to be compared with a placebo before long-term efficacy can be reasonably deduced. The Food and Drug Administration (FDA) requires a 12-week treatment period for industry-initiated hot flash trials, whereas most academic-initiated trials have ranged from 4 to 12 weeks. We have focused on… CONTINUE READING