Efficacy and tolerability of a novel XXXX vaginal ring for relief of menopausal symptoms.

@entity1 @entity172 @entity1109 @entity53 @entity194
OBJECTIVE: To assess the efficacy, tolerability, and acceptance of a vaginal ring delivering the equivalent of 50 or 100 microg per day of @entity53 (E2), compared with placebo, for relief of moderate to severe @entity1109 and urogenital symptoms in postmenopausal @entity1 . METHODS: @entity1 with moderate to severe @entity1109 (seven or more per day or 56 per week average) received 13 weeks of treatment with a vaginal ring delivering 50 microg per day E2 (n = 113) or 100 microg per day E2 (n = 112), or a placebo vaginal ring (n = 108). Severity of @entity1109 was assessed by a daily diary card and the Greene Climacteric Scale. Urogenital signs and symptoms were evaluated via @entity1 and physician assessment and vaginal cytology. @entity1 satisfaction with the vaginal ring was evaluated via questionnaire. RESULTS: Vasomotor symptoms significantly improved in both treatment groups, compared with placebo (P <.05). There was a trend toward greater improvement in @entity1 assessment of urogenital signs with active rings compared with placebo. For @entity1 with @entity194 at baseline (n = 60), the maturation index improved significantly in both treatment groups compared with placebo. Total Greene Climacteric Scale scores significantly improved for both E2 vaginal ring groups (P <.05) compared with placebo. The vaginal rings were well tolerated. Most adverse events were mild or moderate and consistent with @entity172 therapy. CONCLUSION: A novel vaginal ring delivering the equivalent of 50 or 100 microg per day of E2 significantly reduced the number and severity of @entity1109 and improved urogenital symptoms, compared with placebo. The E2 vaginal ring was well tolerated.
