Poster presentations

Abstract

Introduction. The TOTAL study was a 48-week randomized, double-blind, controlled trial to compare efficacy and tolerability in postmenopausal women treated with tibolone 2.5 mg or continuous combined estradiol plus norethisterone acetate (E2/NETA) 1.0/0.5 mg/day. Methods. Hot flushes, vaginal spotting and bleeding patterns were recorded with daily diary cards. Urogenital complaints were assessed with the Local Urogenital Complaints Rating Scale (LUCRS) and breast pain recorded via adverse event reporting. Results. A total of 572 postmenopausal women were included in the trial, of mean age 55 years. For all treatment periods, tibolone caused less bleeding/spotting when compared with E2/NETA. The difference was significant during the first 12 weeks of treatment (P < 0.001) and also during treatment weeks 24–36 (P = 0.019). The relief of vasomotor symptoms was similar for both treatment arms and showed a significant improvement when compared with baseline. Both treatments significantly improved vaginal maturation index and urogenital complaints (dyspareunia, nocturia, urgency, frequency) when compared with baseline. The frequency of breast pain and tenderness was significantly lower in the tibolone group compared to the E2/NETA group (P < 0.001). In the E2/NETA group, 20% of patients who reported vaginal bleeding as an adverse event discontinued the study, compared with none in the tibolone group (P < 0.01). Conclusions. Tibolone 2.5 mg improves menopause-related symptoms such as hot flushes and urogenital complaints as effectively as E2/NETA but has a better tolerability profile due to less irregular vaginal bleeding and breast pain. Hormone therapies and the risk of breast cancer