Efficacy and safety of sildenafil citrate in women with sexual dysfunction associated with female sexual arousal disorder

Objective: Sildenafil citrate (Viagra(R) Pfizer, New York, NY) is indicated for the treatment of erectile dysfunction in men. The nitric oxide-cyclic guanosine monophosphate pathway (NO-cGMP) involved in penile erection and enhanced by sildenafil may also play a role in some components of the female sexual arousal response. The efficacy and safety of sildenafil were evaluated in estrogenized and estrogen-deficient women with sexual dysfunction that included female sexual arousal disorder (FSAD). Methods: Patients were randomized to receive 10-100 mg sildenafil or matching placebo. To assess efficacy, patients completed two global efficacy questions (GEQ), the Life Satisfaction Checklist (LSC), an event log of sexual activity, and a 31-item sexual function questionnaire (SFQ). To assess safety, adverse event (AE) data were recorded. Results: A total of 577 estrogenized and 204 estrogen-deficient women were randomized to treatment. All were diagnosed with FSAD, but it was the primary presenting symptom in only 46% and 50% of women, respectively. Differences in efficacy between sildenafil and placebo were not significant for any patient or partner end points (e.g., the two GEQ the sexual event logs, the LSC, and the SFQ). The main AE were headache, flushing, rhinitis, nausea, visual disturbances, and dyspepsia, which were generally mild to moderate in nature. Conclusions: Any genital physiological effect of sildenafil was not perceived as improving the sexual response in estrogenized or estrogen-deficient women with a broad spectrum of sexual dysfunction that included FSAD. Whether more specific subgroups of women with FSAD could potentially benefit from treatment with sildenafil is an area for future research.