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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.

This European survey reveals that the majority of women experience climacteric symptoms but that their decision whether or not to use HT is highly dependent on their concern about breast cancer risk. An increase in knowledge of the benefits and risks of HT is required for women to make appropriate decisions about hormone use.

Introduction A considerable number of double-blind randomized controlled studies investigating the effects of pharmaceutical intervention on female sexual functioning have been published in recent years. However, a comparison between outcomes of various studies is difficult as no generally accepted/correct approach to research has been established yet. To be able to translate trial results to daily clinical practice, current limitations and issues in drug intervention studies in female sexual dysfunction (FSD) need to be clarified. Aim To evaluate the needs in research into intervention in FSD by reviewing published studies. Methods A systematic review of double-blind randomized controlled intervention trials on FSD. Main Outcome Measures Definitions of study populations, inclusion and exclusion criteria, use of power calculations, outcome measures and treatment duration. Results A total of 25 double-blind randomized controlled trials investigating the effects of pharmaceutical intervention on female sexual functioning have been published. Of these, 11 studies required the diagnosis of FSD as an inclusion criterion. A standard methodology for research in this field is lacking. Significant differences in population inclusion requirements and tools for the measurement of change in sexual functioning were identified as major limiting factors. Conclusions The investigation of FSD is an evolving area in that new definitions and a new model for female sexual functioning have been recently proposed. There is a need for experts in the field and regulating authorities to reach a consensus regarding appropriate inclusion and exclusion criteria for FSD trials and main outcome measures appropriate for the evaluation of drug interventions. This consensus should also determine which treatment effect is considered to be clinically relevant. Treatment efficacy and clinical relevance should be related to outcomes which are meaningful for affected women.

Tibolone 1.25 mg/day for 2 years prevents postmenopausal bone loss in older women and results in a larger increase of BMD both at the lumbar spine and hip than raloxifene.