Clinical Trial: The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.

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

Official Title: A Phase 2a Multi-Centre, Double Blind, Placebo Controlled Cross-Over Trial To Investigate The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women Diagnosed With Female Sexual Arousal

Brief Summary: CP-866,087 is a non-hormonal compound, acting on the central nervous system, which has been shown in animal models to restore sexual function.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks. [ Time Frame: 6 weeks ]
  • Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment. [ Time Frame: 6 weeks ]


Original Primary Outcome: Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment. Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks.

Current Secondary Outcome:

  • Exit interview at end of study. Meaningful Benefit Question at end of study. [ Time Frame: End of study ]
  • Measure of Female Sexual Distress questionnaire after 6 weeks of treatment. [ Time Frame: 6 weeks ]


Original Secondary Outcome:

  • Measure of Female Sexual Distress questionnaire after 6 weeks of treatment.
  • Exit interview at end of study. Meaningful Benefit Question at end of study.


Information By: Pfizer

Dates:
Date Received: June 1, 2007
Date Started: July 2007
Date Completion:
Last Updated: October 27, 2010
Last Verified: October 2010