The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on erectile activity in males suffering from erectile dysfunction as well as examining the safety and toleration of the drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
Single 200mg dose as an oral solution
Placebo for oral solution
Placebo for tablet
Pfizer Investigational Site
Oslo, Norway
Pfizer Investigational Site
Belfast, Northern Ireland, United Kingdom
Pfizer Investigational Site
Leeds, WEST Yorkshire, United Kingdom
Assess effect of single doses of PF-00446687 on erectile function (using the Rigiscan+ device)
Time frame: Day of dosing
Evaluate subjective self-assessment of sexual interest and desire by means of a questionnaire
Time frame: Day of dosing
Diary of sexual activities
Time frame: From day of dosing to 7 days post-dose
PK assessment of PF-00446687 ad sildenafil
Time frame: Day of dosing
Safety and toleration
Time frame: Day of dosing to follow-up
Assess variability of response and repeatability of design between 2 similar doses
Time frame: Comparison of response to be assessed until 7 days post-dose
Assess agouti related protein levels in this population
Time frame: Day of dosing
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Single oral dose 100 mg tablet
Single 125 mg dose as an oral solution
Single 175 mg dose as an oral solution
Single 20 mg dose as an oral solution
Placebo for oral solution
Placebo for tablet
Single oral dose 100 mg tablet