NCT01798667

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Dong-A Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

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

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
DRUG	DA-8031
DRUG	Placebo	Placebo of DA-8031, undistinguishable

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-04-01
• Completion: 2013-09-01
• First posted: 2013-02-26
• Last updated: 2013-08-15

Locations

1 site across 1 country: South Korea