Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction

Phase 3 Study to Evaluate Longterm Safety of Once-a-Day Dosing of Udenafil in the Treatment of Erectile Dysfunction

Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159_EDD_III)

Completer from parent study(DA8159_EDD_III)continued into a 24weeks open-label extension during which they received udenafil once daily. The study concluded with a 4-week ED treatment-free period.

Inclusion Criteria:

• Male patients aged 20 years or more diagnosed with erectile dysfunction(ED)

Exclusion Criteria:

• Had uncontrolled blood pressure
• Had hepatic or renal dysfunction
• Had significant psychiatric disorders or drug abuses
• Was currently under anticancer chemotherapy
• Had a treatments for ED using other phosphodiesterase type 5(PDE-5) inhibitors