Assessing the clinical efficacy of sildenafil for the treatment of female sexual dysfunction.

OBJECTIVE To review the clinical data regarding the efficacy and safety of sildenafil for the treatment of female sexual dysfunction (FSD). DATA SOURCES A MEDLINE search from 1950 to February 2009 was conducted using the key words sildenafil and female sexual dysfunction. Human studies and publication in English were used as primary limits. A combination of several publication-type limits was used to locate the clinical trials (eg, clinical trial, controlled clinical trial, randomized clinical trial). A bibliographic search was also performed of all located articles. STUDY SELECTION AND DATA EXTRACTION Clinical trials involving sildenafil treatment of premenopausal and postmenopausal women with FSD and women with FSD due to concomitant medications and/or disease states were reviewed. DATA SYNTHESIS An increasing number of clinical trials have been published regarding the treatment of FSD with sildenafil. Eight studies demonstrated a possible benefit from treatment for FSD in patients receiving sildenafil, regardless of dose, while 4 trials did not show any significant differences with treatment. It appears that sildenafil might be beneficial for women with FSD caused by diseases such as multiple sclerosis, type 1 diabetes, spinal cord injury, and use of antidepressant medications. CONCLUSIONS Although data suggest a possible role of sildenafil for the treatment of FSD, the information should be interpreted cautiously, as many of the studies included small sample sizes, used inappropriate statistical tests, and used nonvalidated assessment tools. A better FSD classification system and consistent use of validated assessment tools might help alleviate differences among clinical trials and provide a more cohesive foundation for assessing the safety and efficacy of sildenafil for the treatment of FSD.