Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

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

parallel group, fixed dose design

Phase : Phase III

Completed

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-8159 (Udenafil)

Drug

Placebo

Drug

Primary outcomes

IIEF EF domain score

Time frame: 24 weeks

Secondary outcomes

IIEF, IPSS

Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Dong-A Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Phase 3 Study to Evaluate the Efficacy and Safety of Once-a-day Dosing of Udenafil in the Treatment of Erectile Dysfunction

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jan 24, 2013
Registry last updated: Jan 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed