Clinical Research Directory

Inclusion Criteria: Visit 1 (screening) * Male subjects aged 19 to 75 years, inclusive. * Subjects with a history of erectile dysfunction for at least 3 months prior to Visit 1. * Subjects who are expected to have sexual intercourse with the same adult female partner throughout the study period. * Subjects who agree to attempt sexual intercourse at least 4 times on 4 separate days during the run-in period. Visit 2 (Randomization) * Subjects with an International Index of Erectile Function (IIEF) Erectile Function (EF) domain score of ≤25 at Visit 2. * Subjects who attempted sexual intercourse at least 4 times on 4 separate days during the run-in period and demonstrated a sexual intercourse failure rate of ≥50%, as assessed by the Sexual Encounter Profile (SEP). Exclusion Criteria: * Erectile dysfunction associated with premature ejaculation or endocrine disorders (e.g., hypogonadism, hyperprolactinemia, thyroid disorders) * Uncontrolled diabetes mellitus (HbA1c \> 10% at Visit 1) * History of radical prostatectomy or other pelvic surgery * Presence of anatomical penile deformity (e.g., Peyronie's disease, penile angulation, cavernosal fibrosis) * History of major cardiovascular or cerebrovascular disease, including unstable angina, recent myocardial infarction, stroke, uncontrolled arrhythmia, or heart failure * History of retinitis pigmentosa, NAION, or other hereditary retinal degenerative disorders * Clinically significant hepatic or renal impairment * Positive serology for infectious diseases at Visit 1 * Prior failure to respond to PDE-5 inhibitor therapy * Use of prohibited concomitant medications or anticipated need for such medications during the study * Participation in another clinical trial within 30 days prior to Visit 1 * Known hypersensitivity to the study drug or its components