A DOUBLE-BLIND, RANDOMIZED TRIAL COMPARING THE EFFECTS OF TIBOLONE AND CONTINUOUS COMBINED HORMONE REPLACEMENT THERAPY IN POSTMENOPAUSAL WOMEN WITH MENOPAUSAL SYMPTOMS

Objective To compare the effects of two postmenopausal regimens on men opausal symptoms, bleeding episodes, side effects and acceptability. D esign Double-blind, randomised controlled trial. Setting Twenty-nine s ites in Denmark, nine in Norway and six in Sweden. Participants Four h undred and thirty-seven postmenopausal women with menopausal complaint s. None of these women had had a hysterectomy. Interventions Daily tre atment with tibolone 2.5 mg (n = 218) or 17 beta-oestradiol 2 mg plus norethisterone acetate 1 mg (E-2/NETA) (n = 219). Main outcome measure s Hot flushes, sweating episodes, vaginal dryness, assessment of sexua l life and bleeding patterns; at baseline and after 4, 12, 24 and 48 w eeks. Results Treatment with either preparation significantly reduced mean scores for hot flushes, sweating episodes and vaginal dryness. Th e overall discontinuation rate was 28% (tibolone 25%, E-2/NETA 31%; P = 0.14), mostly during the first six months. There was a markedly lowe r cumulative incidence of bleeding or spotting episodes with tibolone compared with E-2/NETA (P < 0.0001), mainly during the first six treat ment cycles. Conclusions Both tibolone and E-2/NETA effectively allevi ate menopausal symptoms. However, tibolone caused significantly fewer bleeding or spotting episodes, which were reflected by lower overall r ates of bleeding, as well as lower drop-out rates due to bleeding.