Objective To compare the effects of two postmenopausal regimens on menopausal symptoms, bleeding episodes, side effects and acceptability.Design Double-blind, randomised controlled trial.Setting Twenty-nine sites in Denmark, nine in Norway and six in Sweden.Participants Four hundred and thirty-seven postmenopausal women with menopausal complaints. None of these women had had a hysterectomy.Interventions Daily treatment with tibolone 2.5 mg (n = 218) or l7p-oestradiol 2 mg plus norethisterone acetate 1 mg (E,lNETA) (n = 219). Main outcome measures Hot flushes, sweating episodes, vaginal dryness, assessment of sexual life and bleeding patterns; at baseline and after 4, 12,24 and 48 weeks.Results Treatment with either preparation significantly reduced mean scores for hot flushes, sweating episodes and vaginal dryness. The overall discontinuation rate was 28% (tibolone 25%, E,/NETA 31%; P = 0.14), mostly during the first six months. There was a markedly lower cumulative incidence of bleeding or spotting episodes with tibolone compared with E,/NETA ( P < O.OOOl), mainly during the first six treatment cycles. Conclusions Both tibolone and E,/NETA effectively alleviate menopausal symptoms. However, tibolone caused significantly fewer bleeding or spotting episodes, which were reflected by lower overall rates of bleeding, as well as lower drop-out rates due to bleeding.

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The vaginal bleeding rate during cycles 4-6 was significantly lower in women using tibolone. Both treatments improved QoL, wellbeing, climacteric symptoms and urogenital symptoms. Breast tenderness was significantly less frequent with tibolone.