Ospemifene: a safe treatment of vaginal atrophy.

OBJECTIVE: Vaginal atrophy is a chronic, progressive medical condition that affects fifty percent of postmenopausal women, causing symptoms like dyspareunia, vaginal dryness, and vaginal irritation. Until recently, the only prescription options were systemic and vaginal estrogen therapies that might be limited by concerns about long-term safety and breast cancer risk. The objective is to analyze the literature about ospemifene, a tissue-selective estrogen receptor modulator (SERM) recently approved for the treatment of vulvovaginal atrophy and dyspareunia and to compare its effects with those of the other SERMs to assess its safety.

MATERIALS AND METHODS: Review. Medline search.

RESULTS: Ospemifene treats vaginal atrophy, and, if compared with other SERMS, it has no or not significant effects on endometrium and thromboembolism. Experimental and animal models suggest an inhibitory effect on the growth of malignant breast tissue. The available clinical data support ospemifene breast safety.

CONCLUSIONS: Ospemifene relieves moderate to severe symptoms of vulvovaginal atrophy, like dryness, irritation and soreness around the genital area, and painful sexual intercourse, in menopausal women. It is well tolerated, and it has neutral effects on endometrium and coagulation. Clinical trials and even long-term studies on breast cancer effects support ospemifene overall safety.