Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 After Oral Administration in Male Patients With Premature Ejaculation

This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the optimal dose of DA-8031 in male patients with premature ejaculation after oral administration on-demand.

The investigators hypothesized that newly-developed DA-8031 would effect in delaying ejaculation in patients with premature ejaculation (PE).

Design:

Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design

Inclusion Criteria:

• Male patients aged with premature ejaculation for more than 6 months.
• PEDT score ≥ 11

Exclusion Criteria:

• IIEF-EF domain ≤ 21
• Serum Creatinine ≥ 2.5 mg/dl
• AST, ALT > 3*Upper limit of normal
• Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>180/100mmHg)
• Subjects with chronic depression, psychiatric or schizophrenia,
• Subjects with alcohol, drug or substance abuse