A randomized double-blind placebo-controlled phase 2 pilot trial evaluating a novel vaginal softgel capsule containing solubilized estradiol

摘要

Objective:The aim of the study was to evaluate the safety and efficacy of vaginal estradiol (E2) softgel capsules for moderate-to-severe symptoms of vulvar and vaginal atrophy (VVA). Previous phase 1 studies showed lower systemic estrogen concentrations with this softgel capsule compared with an approved low-dose vaginal E2 tablet.