OBJECTIVE: To prospectively assess the safety and effectiveness of the 
investigational phosphodiesterase 5 inhibitor avanafil to treat erectile 
dysfunction in men with diabetes mellitus.
PATIENTS AND METHODS: This 12-week, multicenter, double-blind, 
placebo-controlled study conducted between December 15, 2008, and February 11, 
2010, randomized 390 men with diabetes and erectile dysfunction 1:1:1 to receive 
avanafil, 100 mg (n=129), avanafil, 200 mg (n=131), or placebo (n=130). 
Coprimary end points assessed changes in the percentage of sexual attempts in 
which men were able to maintain an erection of sufficient duration to have 
successful intercourse (Sexual Encounter Profile [SEP] 3), percentage of sexual 
attempts in which men were able to insert the penis into the partner's vagina 
(SEP 2), and International Index of Erectile Function erectile function domain 
score.
RESULTS: Compared with placebo, least-squares mean change from baseline to study 
end in SEP 3, SEP 2, and International Index of Erectile Function erectile 
function domain score were significantly improved with both avanafil, 100 mg 
(P≤.002), and avanafil, 200 mg (P<.001). Additional analyses indicated that 
successful intercourse could be initiated in 15 minutes or less through more 
than 6 hours after avanafil dosing. Adverse events most commonly reported with 
avanafil treatment were headache, nasopharyngitis, flushing, and sinus 
congestion.
CONCLUSION: Avanafil was safe and effective for treating erectile dysfunction in 
men with diabetes and was effective as early as 15 minutes and more than 6 hours 
after dosing. The adverse events seen with avanafil were similar to those seen 
with other phosphodiesterase 5 inhibitors.
TRIAL REGISTRATION: clinicaltrials.gov Identifier NCT00809471.