Topical alprostadil (PGE1) for the treatment of female sexual arousal disorder: in-clinic evaluation of safety and efficacy.

This multi-center, randomized, placebo-controlled, crossover design study evaluated the effects of a topical alprostadil solution for the treatment of female sexual arousal disorder (FSAD). A total of 79 naturally or surgically post menopausal women with FSAD were treated with either 100 or 400 micrograms of alprostadil solution and placebo, delivered on separate clinic visits in random order. Study drug was applied to the external genitalia and was followed by 30 minutes of visual sexual stimulation. Study evaluations included investigator assessments of genital vasocongestion and patient assessments of physical and emotional sexual arousal, and sexual satisfaction. Genital vasocongestion in response to PGE1 was significantly greater than placebo (p < 0.0001) at each dose level and at all post dosing time points. Patient assessments of physical and emotional arousal and sexual satisfaction were significantly greater than placebo with the 400 mcg dose, but not with the 100 mcg dose of alprostadil. Topical alprostadil was well tolerated with no reports of significant systemic side effects. The most common adverse event was mild, transient genital burning typically < 1 minute duration. Other side effects were mild-moderate, resolving within two hours of application. These data suggest topical alprostadil should be further researched as a potentially appropriate on-demand therapeutic choice for women experiencing FSAD.