Ospemifene efficacy and safety data in women with vulvovaginal atrophy.

Vulvovaginal atrophy (VVA) is a frequent, underreported and underdiagnosed condition. Ospemifene is a third-generation Selective Estrogen Receptor Modulator (SERM) that has been shown to be effective in women with VVA and dyspareunia, vaginal dryness and vulvar vestibular symptoms. Some of the possible side effects included by FDA and EMA are hot flushes, headache, muscle spasms, vaginal bleeding and vaginal discharge. Ospemifene does not increase the incidence of endometrial cancer or hyperplasia. While the efficacy is comparable with that of estrogenic treatments, ospemifene is not only well tolerated and safe but also reduces bone turnover in postmenopausal women, and available data indicate no safety concerns for breast tissue.