Efficacy and safety of topical alprostadil cream for the treatment of female sexual arousal disorder (FSAD): a double-blind, multicenter, randomized, and placebo-controlled clinical trial.
We evaluated the efficacy and safety of three doses of a novel alprostadil cream in a randomized, double-blind, placebo-controlled study in 94 women presenting with female sexual arousal disorder of at least 6 month s duration. We sent the subjects home with 10 premeasured doses of 500  g, 1000  g, or 1500  g alprostadil or a placebo cream to be applied to the vulvar area prior to vaginal intercourse over a period of 6 weeks. The primary efficacy parameter, the arousal success rate (as measured by diary responses to the Female Sexual Encounter Profile [FSEP]), was highest in the alprostadil 1000  g group and lowest in the 500  g group, but the responses were not different from that of the placebo cream, at the p = 0.05 level, for any of the three alprostadil doses. However, the change from baseline for Item 6 of the Female Sexual Function Index (FSFI; Rosen et al., 2000; satisfaction with arousal during sexual activity) suggested an important dose-related trend (p = 0.173; 1500  g versus placebo). The mean percent responder rate (responder = > 50% arousal success rate with > 3 sexual attempts) suggested a dose-response effect (p = 0.157; 1500  g versus placebo). Adverse events were generally mild or moderate in intensity and mainly involved localized reactions in the genital area.
D000279:Administration, Cutaneous; D000328:Adult; D000527:Alprostadil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000704:Analysis of Variance; D003075:Coitus / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy* / Q000523:psychology; D013997:Time Factors; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014844:Vulva / Q000187:drug effects*
D014665:Vasodilator Agents; D000527:Alprostadil