Topical alprostadil treatment of female sexual arousal disorder.

Objective: To review the pharmacology, pharmacokinetics, efficacy, and safety of topical alprostadil in the treatment of female sexual arousal disorder (FSAD).

Data Sources: A literature search was conducted using MEDLINE (1966-May 2006), EMBASE, and International Pharmaceutical Abstracts with the search terms alprostadil, female, and sexual dysfunction/drug therapy.

Study Selection And Data Extraction: All published and unpublished clinical trials and abstracts involving the efficacy and safety of topical alprostadil use in women were reviewed. Data on file with the manufacturer were also included.

Data Synthesis: Topical alprostadil is a vasodilatory agent under development for the treatment of FSAD. In-clinic application of alprostadil increases genital vasocongestion, vaginal erythema, transudates, and some patient-assessed indices of sexual arousal; however, these effects have not been consistently superior to placebo. Three of 4 trials investigating at-home use of topical alprostadil have demonstrated improvements in achievement of satisfactory levels of sexual arousal and successful sexual encounters in patients with FSAD. Adverse events appear to be mild and localized and consist of burning and itching at the application site.

Conclusions: Two formulations of topical alprostadil are in Phase II clinical trials for the treatment of FSAD. Initial results of clinical trials have demonstrated some beneficial effects on arousal success rates and other subjective measures of sexual arousal; however, these results have been inconsistent and not reproducible in all trials. The results of ongoing clinical studies are needed to further define the role of topical alprostadil in the treatment of FSAD.