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 E(-2)/NETA for the treatment of female sexual dysfunction in naturally menopausal women: Results of a randomized active-controlled trial

IntroductionThere 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.AimTo 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 measureDifferences 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).MethodsA 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.ResultsFour 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 ConclusionsBoth 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.Esme A. Nijland, Willibrord C.M. Weijmar Schultz, Jörgen Nathorst-Boös, Frans A. Helmond, Rik H.W. Van Lunsen, Santiago Palacios, Robert J. Norman, Roel J. Mulder, and Susan R. Davi