The effect of a novel vaginal ring delivering oestradiol acetate on climacteric symptoms in postmenopausal women.

OBJECTIVE: Evaluate the efficacy and acceptability of a novel vaginal ring delivering oestradiol acetate (Menoring) versus oral oestradiol for relief of climacteric symptoms in postmenopausal women. DESIGN: Prospective, multicentre, randomised, double-blind, comparator-controlled, parallel group study. SETTING: Twenty-one centres in the United Kingdom. POPULATION: Postmenopausal women, aged <65 years experiencing > or =20 hot flushes/night sweats per week for two consecutive weeks. METHODS: Patients received a vaginal ring releasing oestradiol acetate at a rate equivalent to 50 microg/day in addition to placebo tablets (vaginal ring group) or oral oestradiol 1 mg/day in addition to placebo vaginal ring (oral group) for 24 weeks. For patients with inadequate control of vasomotor symptoms, dosage was doubled at 12 weeks. Non-hysterectomised women received norethisterone 1 mg/day for 12 days in each 28 day cycle. MAIN OUTCOME MEASURES: Efficacy was assessed by change in climacteric symptoms measured by the Greene Climacteric Scale, as well as mean change in frequency of hot flushes/night sweats. RESULTS: A total of 159 patients were enrolled (84 vaginal ring, 75 oral). Significant improvement (P < 0.05) in mean total Greene Climacteric Scale scores in both treatment groups was observed at 12 and 24 weeks and for every subscale score including anxiety, depression and sexual dysfunction (P < 0.05). In both groups, frequency of hot flushes/night sweats was significantly reduced (P < 0.001) at 12 and 24 weeks. No significant between-group differences were noted at 12 or 24 weeks. CONCLUSIONS: The oestradiol vaginal ring significantly improved climacteric symptoms as measured by Greene Climacteric Scale scores and reduced the frequency of hot flushes/night sweats. Efficacy and safety of vaginal ring oestradiol were comparable with those of oral therapy. Patient evaluations of oestradiol vaginal ring tolerability and acceptability were excellent.