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

Harin Padma-Nathan, Candace Brown, Jane Fendl, Shawki Salem, James Yeager, Ronald Harning

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

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 μg, 1000 μg, or 1500 μg 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 μg group and lowest in the 500 μg 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 μg 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 μg versus placebo). Adverse events were generally mild or moderate in intensity and mainly involved localized reactions in the genital area.

Original languageEnglish (US)
Pages (from-to)329-344
Number of pages16
JournalJournal of Sex and Marital Therapy
Volume29
Issue number5
DOIs
StatePublished - Oct 1 2003

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sexual disorder
Psychological Sexual Dysfunctions
Alprostadil
Randomized Controlled Trials
Placebos
Safety
Arousal
Group
event
Therapeutics
trend
Sexual Behavior

All Science Journal Classification (ASJC) codes

  • Psychology(all)
  • Clinical Psychology
  • Social Sciences (miscellaneous)

Cite this

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. / Padma-Nathan, Harin; Brown, Candace; Fendl, Jane; Salem, Shawki; Yeager, James; Harning, Ronald.

In: Journal of Sex and Marital Therapy, Vol. 29, No. 5, 01.10.2003, p. 329-344.

Research output: Contribution to journalArticle

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