The objective of this study was to determine and compare the minimum time required to achieve penile rigidity greater than or equal to 60% at the base of the penis that is sustained for at least 3 minutes measured by Rigiscan®, following visual sexual stimulation post dose of 100 mg sildenafil citrate and 20 mg tadalafil in men with erectile dysfunction (ED).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
tadalafil 20 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
sildenafil 100 mg tablet by mouth for 2 doses (at Week 0 and Week 1)
Pfizer Investigational Site
Oslo, Norway
Pfizer Investigational Site
Leeds, United Kingdom
The primary efficacy variable was time to onset of penile rigidity greater than or equal to 60% at the base of the penis, measured by Rigiscan, that was sustained for at least 3 minutes following visual sexual stimulation
Time frame: Screening, Week 0, and Week 1
The percentage of subjects who achieved penile rigidity greater than or equal to 60% at the base of the penis, measured by Rigiscan, that was sustained for at least 5 minutes following visual sexual stimulation
Time frame: Screening, Week 0, and Week 1
Time to onset of penile rigidity greater than or equal to 60% at the base of the penis, measured by Regiscan, that was sustained for at least 5 minutes following visual sexual stimulation
Time frame: Screening, Week 0, and Week 1
The percentage of subjects who achieved penile rigidity greater than or equal to 60% at the base of the penis, measured by Regiscan, that was sustained for at least 3 minutes following visual sexual stimulation
Time frame: Screening, Week 0, and Week 1
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