Effect of Udenafil on Spermatogenesis

Effect of Udenafil on Spermatogenesis: A Double-blind, Randomized, Placebo-controlled, Parallel-group Study

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

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction; Spermatogenesis
• Intervention / Treatment: Drug: Placebo; Drug: Udenafil

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Warner Chilcott Investigational Site
  • California
    • 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
      • Warner Chilcott Investigational Site
  • Connecticut
    • Middlebury, Connecticut, United States, 06762
      • Warner Chilcott Investigational Site
  • Florida
    • 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
      • Warner Chilcott Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Warner Chilcott Investigational Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71115
      • Warner Chilcott Investigational Site
  • New Jersey
    • Plainsboro, New Jersey, United States, 08536
      • Warner Chilcott Investigational Site
  • New York
    • 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
      • Warner Chilcott Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Warner Chilcott Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • Warner Chilcott Investigational Site
    • Webster, Texas, United States, 77598
      • Warner Chilcott Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Warner Chilcott Investigational Site
  • Washington
    • Spokane, Washington, United States, 99204
      • Warner Chilcott Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Daily, oral tablet
Active Comparator: Udenafil; Udenafil daily tablet	Drug: Udenafil; Daily tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm Concentration Reduction greater than or equal to 50% at Week 26	Percentage of Subjects with greater than or equal to 50% decrease from baseline in sperm concentration at 26 weeks	26 weeks

Collaborators and Investigators

• Sponsor: Warner Chilcott
• Investigators: Study Director: Herman Ellman, MD, Warner Chilcott

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: October 27, 2010
• First Submitted That Met QC Criteria: October 27, 2010
• First Posted (Estimate): October 29, 2010

Study Record Updates

• Last Update Posted (Estimate): November 30, 2011
• Last Update Submitted That Met QC Criteria: November 29, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Semen characteristics
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Udenafil
• Other Study ID Numbers: PR-00110