Estradiol vaginal inserts (Imvexxy): effective in genitourinary syndrome of menopause without increasing systemic estrogen levels.

Many women suffer from the genitourinary syndrome of the menopause (GSM), in particular pathological changes that occur in the vagina due to the reduction in their production of estrogens. TherapeuticsMD has developed Imvexxy, small softgel capsules that contain solubilized estradiol and that are inserted vaginally by women twice a week, every 3 to 4 days. These vaginal inserts have been found to readily supply estradiol to the vagina and to result in significant improvement in the GSM signs and symptoms these women had been experiencing. At the same time, pharmacokinetic studies have demonstrated that the small doses of estradiol used do not increase systemic blood levels of estrogens above baseline values, thus greatly reducing the likelihood of unwanted systemic effects of estradiol. The placebo used in clinical trials, which only contained the 'inactive' ingredients in Imvexxy, had partial efficacy, the result either of a placebo effect or of the use of MIGLYOL 812 N to keep the estradiol in solution.