The addition of testosterone undecanoate improved specific aspects of sexual function more than treatment with estrogen alone. Improvements in well-being and self-esteem were similar for both treatments. If testosterone undecanoate 40 mg daily should be used for clinical treatment, regular monitoring of androgen serum levels is needed.

Introduction There are some data to suggest that tibolone improves sexual function in postmenopausal women. However, evidence about the effects of tibolone on female sexual dysfunction is lacking. Aim To compare the efficacy on sexual function of tibolone 2.5 mg to continuous combined transdermal estradiol (E2)/norethisterone acetate (NETA) (50 µg/140 µg) in naturally postmenopausal women with sexual dysfunction. Main Outcome Measure Differences between treatment groups in the change from baseline for the composite subscore of the arousal, desire, and satisfaction domains of the self-reported Female Sexual Function Index (FSFI). Methods A multicenter, double-blind, randomized, clinical trial was performed. Sexual function was assessed with the FSFI at baseline, week 12, and week 24. The outcomes of the Female Sexual Distress Scale (FSDS) and the frequency of satisfying sexual events (daily diaries) were secondary end points. Results Four hundred three women, mean age 56, were included. Both therapies improved sexual function assessed by the FSFI. In the per protocol analysis, but not in the intent-to-treat analysis, the increase in FSFI scores was significantly larger in the tibolone group when compared with the E2/NETA patch group at week 24 (P  = 0.036 and P =0.025 for the composite subscore and total FSFI score, respectively). The satisfying sexual event rate increased from three to four times per 28 days at week 24 (P <0.001 from baseline for both groups), with no difference between groups. The FSDS showed a significant decrease from baseline (P <0.001), which was comparable for both treatment groups. Conclusions Both treatments resulted to improved overall sexual function, as determined by scores on the FSFI, an increase in the frequency of sexual events, and a reduction in sexuality-related personal distress. The statistically significant higher FSFI scores in the tibolone group, when compared to the E2/NETA group, may be because of tibolone's combined estrogenic and androgenic properties.

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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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