New Oral Medication for Vulvar and Vaginal Atrophy

The FDA has approved ospemifene (Osphena 60-mg tablets), an oral tissue-selective estrogen agonist/antagonist, for managing dyspareunia caused by vulvar and vaginal atrophy in menopausal women. Ospemifene acts as an estrogen agonist in vaginal tissues. In clinical trials, ospemifene alleviated pain with sexual intercourse and increased vaginal mucosal maturation more than placebo.

Contraindications include estrogen-dependent neoplasia and active or prior venous thromboembolism, stroke, or myocardial infarction. Although ospemifene also acts on the endometrium as an estrogen agonist, no cases of endometrial cancer have been noted in clinical trials. The most commonly reported adverse reactions were hot flashes (8%), vaginal discharge (4%), an…