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

• Status: Unknown status
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

Criteria

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