Pharmacological therapy for female sexual dysfunction: has progress been made?

The investigation of female sexual dysfunction (FSD) is an evolving area in which definitions and models for female sexual functioning are being continually reviewed and revised. The lack of consensus amongst experts in the field and regulating authorities regarding appropriate inclusion and exclusion criteria for FSD trials, and main outcome measures appropriate for the evaluation of drug interventions has somewhat hampered progression in this area. Nonetheless, there is evidence from randomized controlled trials that androgen therapy improves the quality of the sexual experience for postmenopausal women with low libido, and preliminary data that this may also apply to premenopausal women.

Tibolone and transdermal E2/NETA for the treatment of female sexual dysfunction in naturally menopausal women: results of a randomized active-controlled trial.

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 microg/140 microg) 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.

Women's perception of sexuality around the menopause: outcomes of a European telephone survey.

OBJECTIVE: Women's attitudes and experience towards sexuality around the menopause were investigated in Europe by a telephone survey. In addition, it was qualified to what extent reduced sex drive and vaginal dryness affect personal life, taking into account cultural differences. STUDY DESIGN: A survey on 1,805 post-menopausal women (age range: 50-60 years), experiencing at least one menopausal symptom (hot flushes or sleeplessness) or not menstruating for at least 1 year, was conducted in six European countries (United Kingdom, France, Germany, Italy, The Netherlands, Switzerland) by computer-assisted telephone interviewing. A structured interview analysed menopausal profile, sexuality-related menopausal symptoms, mental well-being and attitudes towards sexuality. RESULTS: Apart from hot flushes or sleeplessness, women particularly experienced sexual symptoms, such as reduced sexual desire and vaginal pain/dryness during the menopausal transition: one third (34%) of the women mentioned experiencing a reduced sex drive whereas one half (53%) of the women noticed that they became less interested in sex in spite of the majority of the sample reporting finding it important to maintain an active sex life (71%). Sex is experienced as an important part of the relationship with a partner, especially for Italian and Swiss women and ageing seems to play a critical role in sexual functioning, particularly for Italian and Dutch women. A general positive attitude toward sex was supported by the evidence that almost half of the study sample reported having sexual contact at least four times a month. Mental and sexual well-being interfered with self-worth and enjoyment of life, as did vaginal discomfort. CONCLUSIONS: These data suggest that European middle-aged women experience the menopause as a process that brings about mood and sexual changes able to impair their personal life. However, cultural values and health beliefs influence perception of sexuality at the time of the menopause and will also influence the need for treatment.

The European Menopause Survey 2005: women's perceptions on the menopause and postmenopausal hormone therapy.

OBJECTIVES: To identify and describe current women's thoughts about the menopause, hormone treatment (HT) and perceptions about breast cancer. METHODS: Between December 2004 and January 2005, 4201 postmenopausal women in seven European countries were interviewed via a standardized computer-aided telephone interview protocol. RESULTS: Almost all women reported to have experienced climacteric symptoms, and 63% of the women rated them as being severe. Only 52% of women were aware of the benefits of HT for relief of climacteric symptoms. Although 84% felt that severe symptoms should be treated, only 40% had used HT at some point in time. Thirty-four percent of the women preferring treatment with natural products did so because of the risk of breast cancer associated with HT. HT was recognized by 59% of the women as one of the most important contributors to an increased breast cancer risk. Most women received their information about HT and breast cancer risk from the media. CONCLUSIONS: 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.