Ospemifene for the treatment of postmenopausal vulvar and vaginal atrophy: recommendations for clinical use.

INTRODUCTION: Vulvar vaginal atrophy (VVA), a component of genitourinary syndrome of menopause, is a chronic, progressive medical condition that results from estrogen deficiency at menopause. Ospemifene is a nonhormonal, estrogen receptor agonist/antagonist (ERAA) FDA-approved for the treatment of moderate to severe dyspareunia, a symptom of VVA, due to menopause.

AREAS COVERED: PubMed was searched from inception to March 2015 with keywords ospemifene and vulvar vaginal atrophy; no other similar clinical reviews were found. This is a comprehensive review describing the clinical safety and efficacy of ospemifene for the treatment of dyspareunia and VVA. Preclinical and clinical data suggesting further potential use or benefits of ospemifene for women's health will also be reviewed.

EXPERT OPINION: Ospemifene is an approved oral option for postmenopausal women seeking treatment for VVA with bothersome dyspareunia, particularly for those who have tried and failed over-the-counter options or do not want vaginal therapies. Further clinical studies are needed to evaluate the preclinical and early clinical findings of antagonistic to neutral effect on breast tissue and positive effect on bone, which, in the future, may support the use of ospemifene to prevent bone loss or treat VVA in women at high risk or with breast cancer.