Introduction: Vulvovaginal
atrophy (VVA), a component of the genitourinary syndrome of menopause, is a progressive condition due to decline in
estrogen leading to vaginal and vulvar epithelial changes. Accompanying symptoms of dryness, irritation, burning,
dysuria, and/or
dyspareunia have a negative impact on quality of life.
Ospemifene is a
selective estrogen receptor modulator (
SERM) approved by the FDA for moderate to severe
dyspareunia and vaginal dryness due to postmenopausal VVA. Areas covered: PubMed was searched from inception to March 2019 with keywords
ospemifene and vulvar vaginal
atrophy to review preclinical and clinical data describing the safety and efficacy of
ospemifene for vaginal dryness and
dyspareunia due to VVA. Covered topics include efficacy of
ospemifene on vaginal cell populations, vaginal pH, and most bothersome VVA symptoms; imaging studies of vulvar and vaginal tissues; effects on sexual function; and safety of
ospemifene on endometrium, cardiovascular system, and breast. Expert opinion:
Ospemifene is significantly more effective than placebo in all efficacy analyses studied, working through
estrogen receptors and possibly
androgen receptors. Safety as assessed by adverse events was generally comparable to that with placebo and to other
SERMs, and/or adverse events were not clinically meaningful. No cases of endometrial or
breast cancer were reported.