Ospemifene: A Novel Option for the Treatment of Vulvovaginal Atrophy

Abstract

Ospemifene—a third-generation selective estrogen receptor modulator approved by the Food and Drug Administration in 2013—is an oral medication for the treatment of dyspareunia. In postmenopausal women with vulvovaginal atrophy, ospemifene significantly improves the structure and pH levels of the vagina, reducing dyspareunia. It is available as a 60-mg tablet; hence, women who may have had prior difficulty with vaginal administration or on-demand use of nonprescription lubricants and moisturizers would likely prefer this form of treatment. Preclinical studies demonstrated that ospemifene has an estrogen agonist action on the bone, reducing the cell proliferation of ductal carcinoma in an in situ model. Studies evaluating the safety of treatment for up to 52 weeks have shown that ospemifene is a safe medication with minimal impact on the endometrium. Further studies with larger number of subjects are necessary to better conclude its effects and long-term safety.

Therapeutic Approaches to Atrophic Vaginitis in Postmenopausal Women: A Systematic Review with a Network Meta-analysis of Randomized Controlled Trials

“…Recently, some clinical trials have shown that TSEC containing bazedoxifene with estrogen treatment had effects on endometrial changes, decreased menopausal symptoms, and decelerated postmenopausal loss of bone mass. 9 10 Estriol is a type of estrogen; tablets containing a low dose of estriol have been promoted for maturation and proliferation of the vaginal epithelial layer. A beneficial profile of the tablet has been indicated in diverse small clinical studies.…”

Understanding the Interplay Between Premenstrual Dysphoric Disorder (PMDD) and Female Sexual Dysfunction (FSD)

“…Contraindications include uncontrolled hypertension, cardiovascular disease, and concurrent use of indomethacin or naltrexone [ 75 ]. Topical estradiol, ospemifene, and synthetic dehydroepiandrosterone (DHEA) have been approved to treat VVA and dyspareunia; however, this diagnosis only applies to the postmenopausal population and is therefore not in the scope of this review [ 76 , 77 , 78 ].…”

Post-menopausal vulvovaginal atrophy — an overview of the current treatment options

“…The ospemifene therapy increases the risk of vein thromboembolism (1.45/1000 women in the ospemifene group and 1.04/1000 women in the placebo group), thus this treatment is contraindicated in women with thromboembolic disease or a history of these condition. Ospemifene has met the requirements of FDA (The Food and Drug Administration) for primary efficacy in vaginal atrophy and has recently been approved by the European Medicines Agency (EMA) to treat moderate-to-severe VVA in postmenopausal women who are not subject to local vaginal estrogen therapy [43,44]. Lasofoxifene is the next drug in this group.…”