drugset / Trial / NCT00324948

Topical Alprostadil for Female Sexual Arousal Disorder

NCT00324948

Phase 2 Completed 300 enrolled VIVUS LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

Approximately 300 patients with female sexual arousal disorder who meet eligibility criteria will be enrolled and randomized to receive either active drug or matching placebo. After a two-month, non-treatment period, patients will receive study drug for 6 months and will record information about sexual encounters in a daily diary. Study drug will be applied directly to the genital area 30-60 minutes before initiation of sexual activity. The endpoint of the study is based on the use of a standard measure of sexual function (FSEP).

Timeline

Start
2004-09
Primary completion
2006-08
Completion
2006-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Alprostadil Unknown Topical