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Effect of Udenafil on Spermatogenesis

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: NCT01230541
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : November 30, 2011
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Brief Summary:
Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects on semen characteristics.

Condition or disease Intervention/treatment Phase
Spermatogenesis Erectile Dysfunction Drug: Placebo Drug: Udenafil Phase 1

Detailed Description:
Safety Study in male subjects with no or mild ED (erectile dysfunction)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Effect of Udenafil on Spermatogenesis: A Double-blind, Randomized, Placebo-controlled, Parallel-group Study
Study Start Date : September 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Daily, oral tablet

Active Comparator: Udenafil
Udenafil daily tablet
Drug: Udenafil
Daily tablet




Primary Outcome Measures :
  1. Sperm Concentration Reduction greater than or equal to 50% at Week 26 [ Time Frame: 26 weeks ]
    Percentage of Subjects with greater than or equal to 50% decrease from baseline in sperm concentration at 26 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No or mild ED (erectile dysfunction) willing & able to provide 2 semen samples without the use of PDE-5 inhibitor or other excluded medication or devices on 2 separate days during screening and at Weeks 12 & 26
  • BMI (body mass index) between 19 and 31 kilogram/meter squared

Exclusion Criteria:

  • New onset coronary artery disease within last 3 months, history of myocardial infarction or cardiac surgical procedure within last 6 months or sudden cardiac arrest
  • Nitrate medications for angina pectoris
  • Used of anti-arrhythmic drug treatment or device
  • Congestive heart failure
  • Uncontrolled diabetes
  • Stroke or transient ischemic attack (TIA) within last 6 months
  • Bleeding disorder or history of GI bleeding within last 12 months
  • Cancer chemotherapy
  • History of alcohol or drug abuse

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): NCT01230541


Locations
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United States, Alabama
Warner Chilcott Investigational Site
Huntsville, Alabama, United States, 35801
United States, California
Warner Chilcott Investigational Site
Anaheim, California, United States, 92801
Warner Chilcott Investigational Site
San Diego, California, United States, 92103
Warner Chilcott Investigational Site
San Diego, California, United States, 92120
Warner Chilcott Investigational Site
Tarzana, California, United States, 91356
United States, Connecticut
Warner Chilcott Investigational Site
Middlebury, Connecticut, United States, 06762
United States, Florida
Warner Chilcott Investigational Site
Aventura, Florida, United States, 33180
Warner Chilcott Investigational Site
Clearwater, Florida, United States, 33759
Warner Chilcott Investigational Site
Doral, Florida, United States, 33166
Warner Chilcott Investigational Site
Ocala, Florida, United States, 34474
Warner Chilcott Investigational Site
Pinellas Park, Florida, United States, 33782
United States, Georgia
Warner Chilcott Investigational Site
Atlanta, Georgia, United States, 30342
United States, Louisiana
Warner Chilcott Investigational Site
Shreveport, Louisiana, United States, 71115
United States, New Jersey
Warner Chilcott Investigational Site
Plainsboro, New Jersey, United States, 08536
United States, New York
Warner Chilcott Investigational Site
Garden City, New York, United States, 11530
Warner Chilcott Investigational Site
Great Neck, New York, United States, 11021
Warner Chilcott Investigational Site
Purchase, New York, United States, 10577
Warner Chilcott Investigational Site
Williamsville, New York, United States, 14221
United States, Ohio
Warner Chilcott Investigational Site
Cincinnati, Ohio, United States, 45212
United States, Texas
Warner Chilcott Investigational Site
San Antonio, Texas, United States, 78229
Warner Chilcott Investigational Site
Webster, Texas, United States, 77598
United States, Virginia
Warner Chilcott Investigational Site
Norfolk, Virginia, United States, 23507
United States, Washington
Warner Chilcott Investigational Site
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Warner Chilcott
Investigators
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Study Director: Herman Ellman, MD Warner Chilcott
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Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01230541    
Other Study ID Numbers: PR-00110
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: November 30, 2011
Last Verified: November 2011
Keywords provided by Warner Chilcott:
Semen characteristics
Erectile Dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action