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Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

This study has been completed.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ) Identifier:
First received: January 22, 2013
Last updated: January 23, 2013
Last verified: January 2013

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

parallel group, fixed dose design

Phase : Phase III

Condition Intervention Phase
Erectile Dysfunction Drug: DA-8159 (Udenafil) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ):

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

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

Enrollment: 349
Study Start Date: April 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-8159 dose 1
Drug: DA-8159 (Udenafil)
Experimental: DA-8159 dose 2
Drug: DA-8159 (Udenafil)
Placebo Comparator: Placebo Drug: Placebo


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Dong-A Pharmaceutical Co., Ltd. Identifier: NCT01774864     History of Changes
Other Study ID Numbers: DA8159_EDD_III
Study First Received: January 22, 2013
Last Updated: January 23, 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 processed this record on August 22, 2017