Vulvar and vaginal atrophy (VVA) is a chronic, progressive medical condition 
prevalent among postmenopausal women, which produces symptoms such as 
dyspareunia, vaginal dryness, and vaginal irritation. Currently, the only 
prescription options are systemic and vaginal estrogen therapies that may be 
limited by concerns about long-term safety and breast cancer risk. Ospemifene is 
a tissue-selective estrogen agonist/antagonist (a selective estrogen receptor 
modulator) recently approved by the US Food and Drug Administration for 
treatment of dyspareunia, a symptom of VVA, due to menopause. Ospemifene, the 
first nonestrogen oral treatment for this indication, may provide an alternative 
to treatment with estrogen. Animal models with ospemifene suggest an inhibitory 
effect on growth of malignant breast tissue, but animal data cannot necessarily 
be extrapolated to humans. Clinical trials, including 3 long-term studies 
assessing the overall safety of ospemifene, support that ospemifene is generally 
well tolerated, with beneficial effects on the vagina, neutral effects on the 
breast, and minimal effects on the endometrium.