Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

Phase 3

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: DA-8159 (Udenafil); Drug: Placebo

• Registration Number: NCT01774864
• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

Brief Summary

Study Design : multi-center, double-blind, placebo-controlled, randomized,

parallel group, fixed dose design

Phase : Phase III

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-23
• Last Update Submitted: 2013-01-23
• Study First Posted: 2013-01-24
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 349

Inclusion Criteria

• Male patients aged 20 years or more diagnosed with ED

Exclusion Criteria

• Had uncontrolled blood pressure
• Had hepatic or renal dysfunction
• Was currently under anticancer chemotherapy
• Had a treatments for ED using other PDE-5 inhibitors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-8159 dose 1	DA-8159 (Udenafil)	Udenafil
DA-8159 dose 2	DA-8159 (Udenafil)	Udenafil
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
IIEF EF domain score	24 weeks

Secondary Outcome Measures

Name	Time	Method
IIEF, IPSS	24 weeks