Efficacy and safety of ultra-low-dose Vagifem (10 mcg)

Janet A Chollet^1,2
1Beth Israel Deaconess Medical Center, Boston, MA, USA; ²Pear Tree Pharmaceuticals, Waltham, MA, USA

Abstract: Vulvovaginal atrophy [VVA] is defined as inflammation of the vaginal epithelium due to atrophy secondary to decreased levels of circulating estrogen. There is currently only one approved method for the treatment of VVA, and that is the administration of exogenous estrogens. Overall, the ideal VVA treatment must have benefits, minimize risks, and enhance compliance in the patient while optimizing cost-effectiveness. Unfortunately, of the approximate 25% of symptomatic women that are thought to seek medical help, the proportion that receives hormone therapy may be small and its duration of use is short. Women have been very reluctant to take hormone therapy due to widely publicized results of the risks associated with hormone therapy. Thus, while menopausal hormone therapy was once accepted as the ideal approach for optimizing changes associated with menopause, prospective randomized clinical trials have challenged that view and have led to a marked decrease in the use of such therapy and increased search for low-dose therapies. This article will highlight the efficacy and safety of recently FDA-approved Vagifem (10 mcg) in treatment of VVA.

Keywords: vulvovaginal atrophy, estradiol, menopause