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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Nedlands, Western Australia, Australia
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
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
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