Ospemifene May Not Treat Vulvar Atrophy: A Report of Two Cases.

INTRODUCTION: Ospemifene (Osphena, Shionogi Inc, Florham, NJ, USA) is an estrogen agonist and antagonist approved by the U.S. Federal Drug Administration for the treatment of "moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause." Although published, peer-reviewed, placebo-controlled studies have shown objective improvement in dyspareunia and in vaginal atrophy, there are no published data that have assessed changes in vulvar atrophy after the use of ospemifene.

AIM: To present two cases of women with severe vulvar atrophy that showed no improvement with the use of ospemifene.

METHODS: A review of two recent cases of a clinic specializing in the treatment of vulvovaginal disorders was performed. Case 1 was a 53-year-old menopausal woman who presented with non-provoked vulvar and vaginal discomfort and introital dyspareunia. She had used ospemifene 60 mg/d for 1.5 years without improvement in her symptoms before presentation. Case 2 was a 57-year-old menopausal woman who also presented with non-provoked vulvar rawness, burning, irritation, vaginal dryness, and introital dyspareunia. She had started ospemifene 60 mg/d 1 year before presentation and reported mild improvement in her vaginal dryness but no improvement in her vulvar irritation or introital dyspareunia.

MAIN OUTCOME MEASURES: Change in vulvar atrophy and introital dyspareunia.

CONCLUSION: These cases highlight the need to perform additional clinical trials that specifically assess the efficacy of ospemifene for changes in vulvar atrophy.