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

OBJECTIVE: To assess the efficacy, tolerability, and acceptance of a vaginal ring delivering the equivalent of 50 or 100 microg per day of estradiol (E2), compared with placebo, for relief of moderate to severe vasomotor symptoms and urogenital symptoms in postmenopausal women.

METHODS: Women with moderate to severe vasomotor symptoms (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 vasomotor symptoms was assessed by a daily diary card and the Greene Climacteric Scale. Urogenital signs and symptoms were evaluated via patient and physician assessment and vaginal cytology. Participant 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 patient assessment of urogenital signs with active rings compared with placebo. For women with vaginal atrophy 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 estrogen 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 vasomotor symptoms and improved urogenital symptoms, compared with placebo. The E2 vaginal ring was well tolerated.