Clinical Trial: An Open-Label, Extension Study Evaluating the Safety, Toleration, and Efficacy of Sildenafil in Women With Sexual Arousal Disorder

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

Official Title: An Open-Label, Multi-Center Extension Study To Evaluate The Safety, Toleration And Sustained Efficacy Of Oral Sildenafil Administered To Women Who Have Been Diagnosed With Female Sexual Arousal Disord

Brief Summary: The purpose of this study is to evaluate the safety and toleration of oral sildenafil administered as required by women with Female Sexual Arousal Disorder (FSAD) who successfully complete one of the following Pfizer-sponsored, 12-week, double-blinded clinical trials: A1481082 or A1481123. Addition of this 52-week open-label extension will increase the total duration of sildenafil exposure to 64 weeks. Sustained efficacy will also be evaluated after 3 and 6 months of open-label therapy.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Safety/toleration of oral sildenafil. [ Time Frame: Continuous ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The score for each of the individual questions 3,5 and 9 on the SQoL-F [ Time Frame: Week 14 and Week 26 ]
  • The total satisfaction score on the Inventory of Treatment Satisfaction (ITS-modified EDITS) [ Time Frame: Week 14 and Week 26 ]
  • The score for each of the individual questions 3,5,6 and 7 on the ITS-modified EDITS [ Time Frame: Week 14 and Week 26 ]
  • The Arousal-lubrication Domain from the SFQ. The score for this domain is the sum of scores from Questions 11 and 12 from the SFQ [ Time Frame: Week 14 and Week 26 ]
  • The Arousal-sensation Domain from the SFQ. The score for this domain is sum of scores from Questions 7,8,9 and 10 from the SFQ. [ Time Frame: Week 14 and Week 26 ]
  • The total Quality of Life score on the Sexual Quality of Life (SQoL-F) [ Time Frame: Week 14 and Week 26 ]
  • The Desire domain from the SFQ. Specifically, the sum of scores from questions 1,2,3,4,15 and 28 (frequency of pleasurable thoughts, wanted to be touched, wanted sex, initiated sex, had sex with penetration, looked forward to sex, respectively). [ Time Frame: Week 14 and Week 26 ]
  • Question 16 from the SFQ at Weeks 14 and 26 (enjoyment of penetration and intercourse). [ Time Frame: Week 14 and Week 26 ]
  • The Orgasm domain from the SFQ. The score for this domain is the sum of scores from questions 24,25 and 26 (orgasm frequency, level of pleasure and ease in achieving, respectively). [ Time Frame: Week 14 and Week 26 ]
  • The individual questions of the Orgasm domain. [ Time Frame: Week 14 and Week 26 ]
  • SFQ Question 27 (confidence as sexual partner). [ Time Frame: Week 14 and Week 26 ]
  • SFQ Question 29 (disappointment with response). [ Time Frame: Week 14 and Week 26 ]
  • Global Efficacy Question (SFQ Question 34, satisfaction with whole of sexual life) [ Time Frame: Week 14 and Week 26 ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: March 31, 2008
Date Started: January 2003
Date Completion:
Last Updated: September 3, 2008
Last Verified: September 2008