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.