Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil

Inclusion Criteria:

• male subjects aged 19 to 70 with history of erectile dysfunction for at least 6 months

• subjects have stable monogamous relationships

• their partners are free from pregnancy and lactation and well prevent conception

• subjects consented to participate in the clinical study in writing

• subjects attempted sexual intercourse at least 4 times in separate days during 4weeks' free run-in period, and failure rate is over 50%

Exclusion Criteria:

• history of spinal cord injury or radical prostatectomy

• subjects whose penises are anatomically deformed

• erectile dysfunction due to neurogenic or endocrine cause

• subjects who have uncontrolled major psychiatric disorder and do not accept therapiesor have significant neurological abnormalities

• history of cancer chemotherapy within 1 year

• subjects who are addicted to alcohol or have continuously misused dependent drugs

• subjects who have hepatic dysfunction(GOP,GPT ≥ 3xUNL) or renal dysfunctions(serumcreatinine > 2.0)

• subjects who have uncontrollable diabetes(FPG>180)

• subjects sho have proliferative diabetic retinopathy

• history of stroke, transient ischemic attacks, myocardial infarction, heart failurethat needs to be medically treated, unstable angina or fatal arrhythmia or coronaryartery bypass graft within 6 months

• serious hypotension or uncontrollable severe hypertension

• hematological disorders that is likely to be developed into priapism such as sicklecell disease, multiple myeloma, leukemia

• subjects who have retinitis pigmentosa

• subjects who suffered from serious GI bleeding disorder within 1 year

• subjects who took other PDE5 inhibitors or ED therapies within 2 weeks

• subjects who use non-concomitant medications(Nitrate/NO donors, Androgens,anti-androgen, trazodone, Anticoagulant,over-the-counter drugs known to inhibit theactivity of CYP3A4)

• history of hypersensitivity to the PDE5 inhibitors or not responded to them

• subjects who have hypoactive sexual desire

• subjects who have no intention of having sexual intercourses 4 times in separate daysduring 4 weeks' free run-in period

• subjects who took other investigational products within 30 days before this clinicalstudy

• subjects who are judged to be unsuitable to the clinical study by other reasons