Clinical Trial: Study to Investigate Effect of Sildenafil on Clitoral Engorgement as Measured by Magnetic Resonance Imaging (MRI) in Pre-Menopausal Women With Female Sexual Arousal Disorder
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double Blind, Placebo Controlled 2-Way Cross-Over Study to Assess the Clitoral Engorgement Response as Measured by Non-Contrast Magnetic Resonance Imaging (MRI) in Women
Brief Summary: The purpose of this study is to investigate the effect of 100 mg sildenafil on clitoral engorgement in pre-menopausal women, as well as examining the safety and toleration of the drug.
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome: To determine the % of subjects who respond within 30 minutes of dosing by achieving an increase in clitoral engorgement >50% from baseline measured by MRI following audio/visual sexual stimulation in females with FSAD. [ Time Frame: Up to 30 minutes post-dose ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To determine the % of subjects who respond to sildenafil 100mg by achieving an increase in clitoral engorgement >50% from baseline within 40, 50 and 60 minutes of dosing respectively. [ Time Frame: Up to 60 minutes post-dose ]
- To assess safety and toleration of sildenafil 100mg by adverse event monitoring, laboratory safety testing and physical examination findings. [ Time Frame: 30 days post-dose ]
- Assess plasma levels of sildenafil and metabolite [ Time Frame: Day of dosing ]
Original Secondary Outcome: Same as current
Information By: Pfizer
Dates:
Date Received: March 17, 2008
Date Started: April 2004
Date Completion:
Last Updated: April 4, 2008
Last Verified: April 2008
