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 4 weeks' 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 therapies or 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(serum creatinine > 2.0)
• subjects who have uncontrollable diabetes(FPG>180)
• subjects sho have proliferative diabetic retinopathy
• history of stroke, transient ischemic attacks, myocardial infarction, heart failure that needs to be medically treated, unstable angina or fatal arrhythmia or coronary artery bypass graft within 6 months
• serious hypotension or uncontrollable severe hypertension
• hematological disorders that is likely to be developed into priapism such as sickle cell 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 the activity 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 days during 4 weeks' free run-in period
• subjects who took other investigational products within 30 days before this clinical study
• subjects who are judged to be unsuitable to the clinical study by other reasons