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

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Abstract
Background: Sildenafil is indicated for the treatment of erectile dysfunction. The nitric oxide–cyclic guanosine monophosphate pathway involved in penile erection also may be important in some components of the female sexual arousal response during sexual stimulation. Objective: To evaluate efficacy and safety of sildenafil in estrogenized women with sexual dysfunction that included female sexual arousal disorder (FSAD). Methods: Patients received sildenafil (10, 50, or 100 mg) or placebo, to be taken as needed about 1 hour before sexual activity but not more than once daily for 12 weeks. Patients completed a global efficacy questionnaire, a sexual function questionnaire, the Life Satisfaction Checklist, and an event log of sexual activity. An optional partner questionnaire was included. Adverse event data were recorded. Results: There were 583 women randomized to treatment; FSAD was diagnosed in all the women, but it was the primary presenting symptom in only 46%. Hypoactive sexual desire disorder, female orgasmic disorder, and dyspareunia were the primary symptoms in 28%, 17%, and 9%, respectively. Differences between the two treatment groups were not significant for all patient and partner endpoints. The main adverse events were headache, flushing, rhinitis, nausea, abnormal vision, and dyspepsia, which were generally mild or moderate. There was one serious treatment-related adverse event (menorrhagia). Conclusions: Any genital physiologic effect of sildenafil administered as needed for 12 weeks was not perceived as improving the sexual response in estrogenized women with sexual dysfunction that included FSAD. Treatment with sildenafil was well tolerated in this patient population.

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