Clinical Trial: Topical Alprostadil for Female Sexual Arousal Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind, Randomized, 6-Month Evaluation of the Safety and Efficacy of Topical Alprostadil in Hysterectomized Women With Female Sexual Arousal Disorder (FSAD)

Brief 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).

Detailed Summary: This is a multicenter, double-blind, randomized, placebo-controlled, parallel-design study involving about 300 women who are 21-60 years of age inclusive, who have undergone a hysterectomy (with or without oophorectomy), and who have a primary diagnosis of FSAD. The diagnosis of FSAD will be made based on a medical and sexual history and confirmed using a structured interview by trained personnel. Study subjects will undergo a 2-month non-treatment run-in period followed by a 6-month period of blinded study therapy. Study drug is applied topically to the genitalia 30-60 minutes prior to initiation of sexual activity. Study subjects will complete several questionnaires at various times during the study and will complete a daily diary. The study endpoint is based on the FSEP and other standard questionnaires, as well as safety and tolerability of study drug.
Sponsor: VIVUS, Inc.

Current Primary Outcome: FSEP

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • FSFI
  • Global assessment
  • Adverse events


Original Secondary Outcome: Same as current

Information By: VIVUS, Inc.

Dates:
Date Received: May 9, 2006
Date Started: September 2004
Date Completion:
Last Updated: March 9, 2009
Last Verified: March 2009