Study Type--Therapy (RCT) Level of Evidence 1b. What's known on the subject? and 
What does the study add? Avanafil is a potent selective phosphodiesterase type 5 
(PDE5) inhibitor newly developed for treating erectile dysfunction (ED). 
Preclinical and clinical phase I studies showed that avanafil had enhanced 
selectivity, faster onset of action and a favourable side-effect profile 
relative to currently available PDE5 inhibitors. As the result of phase III 
clinical trial for the efficacy and safety of avanafil treatment (100 and 200 
mg), taken as needed over a period of 12 weeks, in Korean patients with ED, 
avanafil is an effective and well-tolerated therapy for ED of broad-spectrum 
aetiology and severity.
OBJECTIVE: • To evaluate the efficacy and safety of avanafil, a new potent 
selective phosphodiesterase type 5 (PDE5) inhibitor, in patients with erectile 
dysfunction (ED).
PATIENTS AND METHODS: • The present study was a multicentre, randomized, 
double-blind, placebo-controlled, fix-dosed phase three clinical trial involving 
200 patients with ED. • The subjects were treated with placebo or avanafil (100 
or 200 mg) for 12 weeks and were asked to complete the International Index of 
Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the 
Global Assessment Questionnaire (GAQ). • The primary outcome variable was the 
change from baseline for IIEF erectile function domain (EFD) score. • The 
secondary outcome variables were SEP Q2 and Q3, the shift to normal rate (EFD ≥ 
26), and response to the GAQ.
RESULTS: • Compared with placebo, patients who took 100 or 200 mg of avanafil 
had significantly improved IIEF-EFD score. • There were similar results when 
comparing Q2 and Q3 in the SEP diary and the GAQ. • Flushing was the most common 
treatment-related adverse event. • Most adverse events were transient and mild 
or moderate in severity.
CONCLUSION: • Avanafil is an effective and well-tolerated therapy for ED of 
broad-spectrum aetiology and severity.