PURPOSE: We examined the therapeutic effects of avanafil 15 minutes after dosing 
in men with mild to severe erectile dysfunction.
MATERIALS AND METHODS: This randomized, double-blind, placebo controlled, 
12-week study (4-week run-in and 8-week treatment) randomized 145 men to 
placebo, 147 to avanafil 100 mg and 148 to avanafil 200 mg on demand. The 
primary efficacy variable was the per subject proportion of sexual attempts 
during the treatment period in which subjects achieved erection sufficient for 
vaginal penetration within approximately 15 minutes after dosing as measured by 
a stopwatch. The attempt had to enable successful completion of sexual 
intercourse according to SEP question 3.
RESULTS: Significantly greater mean per subject percentages of successful 
intercourse attempts within approximately 15 minutes after dosing were observed 
for avanafil 100 mg (mean 25.9%, LS mean ± SE 24.7% ± 2.9%) and 200 mg (mean 
29.1%, LS mean 28.2% ± 2.9%) vs placebo (mean 14.9%, LS mean 13.8% ± 2.9%, p = 
0.001 and <0.001, respectively). After treatment we noted a statistically 
significant difference between avanafil and placebo in the average per subject 
proportion of successful intercourse attempts according to SEP question 3 as 
early as 10 minutes in the 200 mg group and 12 minutes in the 100 mg group. 
Treatment emergent adverse events included headache, upper respiratory tract 
infection and nasal congestion, and most such events were mild or moderate in 
severity.
CONCLUSIONS: Avanafil was efficacious within approximately 15 minutes of dosing 
compared to placebo. A statistically significant treatment difference in the 
percentage of successful sexual attempts was demonstrated as early as 10 minutes 
after treatment.