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Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01774864
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : January 24, 2013
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )

Brief Summary:

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

parallel group, fixed dose design

Phase : Phase III

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: DA-8159 (Udenafil) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study to Evaluate the Efficacy and Safety of Once-a-day Dosing of Udenafil in the Treatment of Erectile Dysfunction
Study Start Date : April 2011
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: DA-8159 dose 1
Drug: DA-8159 (Udenafil)
Experimental: DA-8159 dose 2
Drug: DA-8159 (Udenafil)
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. IIEF EF domain score [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. IIEF, IPSS [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774864

Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Principal Investigator: S W Kim, MD, PhD the Catholic University of Korea St. Mary's Hospital
Principal Investigator: D G Moon, MD, PhD Korea University Guro Hospital
Principal Investigator: J J Kim, MD, PhD Korea University Anam Hospital
Principal Investigator: N C Park, MD, PhD Pusan National University Hospital
Principal Investigator: S W Lee, MD, PhD Samsung Medical Center
Principal Investigator: J S Paick, MD, PhD Seoul National University Hospital
Principal Investigator: T Y Ahn, MD, PhD Asan Medical Center
Principal Investigator: K H Moon, MD, PhD Yeungnam University Hospital
Principal Investigator: W S Chung, MD, PhD Ewha Womans University
Principal Investigator: K S Min, MD, PhD Inje University
Principal Investigator: J K Park, MD, PhD Chonbuk National University Hospital
Principal Investigator: D Y Yang, MD, PhD Kangdong Sacred Heart Hospital

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01774864     History of Changes
Other Study ID Numbers: DA8159_EDD_III
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action