Clinical Trial: Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy

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

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction Following

Brief Summary: The objectives of this study are to evaluate the safety and efficacy of two doses of avanafil in the treatment of adult males for erectile dysfunction following bilateral nerve-sparing radical prostatectomy.

Detailed Summary:
Sponsor: VIVUS, Inc.

Current Primary Outcome:

  • Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse [ Time Frame: Baseline, Week 12 ]
    Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?"
  • The Change in Percentage of Sexual Attempts in Which Subjects Are Able to Insert the Penis Into the Partner's Vagina [ Time Frame: Baseline, Week 12 ]
    Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 "Were you able to insert your penis into your partner's vagina?"
  • Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score [ Time Frame: Baseline, End of Treatment (up to 12 weeks) ]
    Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total scores from questions 1-5 & 15 range from 1 to 30. A higher score indicates better erectile function.


Original Primary Outcome:

  • The change in percent of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse [ Time Frame: Week 12 ]
  • The change in percent of sexual attempts in which subjects are able to insert the penis into the partner's vagina [ Time Frame: Week 12 ]
  • The Change in Score on the Erectile Function Domain of the IIEF Questionnaire [ Time Frame: Week 12 ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: VIVUS, Inc.

Dates:
Date Received: May 5, 2009
Date Started: April 2009
Date Completion:
Last Updated: September 14, 2012
Last Verified: September 2012