EFFECTS AND ACCEPTABILITY OF A NEW 17-BETA-ESTRADIOL-RELEASING VAGINAL RING IN THE TREATMENT OF POSTMENOPAUSAL COMPLAINTS

The treatment of postmenopausal symptoms was studied in 26 healthy women using a new synthetic rubber (Kraton D 2109) vaginal ring containing 53 mg of 17beta-oestradiol. All women were postmenopausal, at least 6 months after the last vaginal bleeding and suffering from daily hot flushes. The study was conducted in a double-blind placebo-controlled intrapatient cross-over fashion, and the study period was 6 months. The rings used give an initial in vitro release rate of 0.4 mg/E2 per day. The in vitro release rate decreases to about 0.2 mg/day after 20 days and levels off asymptotically to about 0.1 mg/day after 50 days. Serum E2 levels equivalent to the follicular phase of the normal menstrual cycle were measured after 1 month's use, and serum E2 level stayed above postmenopausal levels throughout the study period. FSH was suppressed during use of the E2-releasing vaginal ring, while LH showed no statistically significant suppression in continued use. Postmenopausal complaints were recorded by Visual Analogue Scales (VAS) as judged by both the patient and the examining doctor; all complaints had favourable outcomes during use of the E2-releasing vaginal ring without deterioration of symptoms during use of the placebo ring. No serious side-effects were encountered, and the possibility of managing all postmenopausal complaints with intravaginal oestrogen treatment is discussed.