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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

Tracking Information
First Submitted Date  ICMJE October 27, 2010
First Posted Date  ICMJE October 29, 2010
Last Update Posted Date November 30, 2011
Study Start Date  ICMJE September 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Udenafil on Spermatogenesis
Official Title  ICMJE Effect of Udenafil on Spermatogenesis: A Double-blind, Randomized, Placebo-controlled, Parallel-group Study
Brief Summary Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects on semen characteristics.
Detailed Description Safety Study in male subjects with no or mild ED (erectile dysfunction)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition  ICMJE
  • Spermatogenesis
  • Erectile Dysfunction
Intervention  ICMJE
  • Drug: Placebo
    Daily, oral tablet
  • Drug: Udenafil
    Daily tablet
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Udenafil
    Udenafil daily tablet
    Intervention: Drug: Udenafil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2011)
239
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2010)
200
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01230541
Other Study ID Numbers  ICMJE PR-00110
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Warner Chilcott
Study Sponsor  ICMJE Warner Chilcott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Herman Ellman, MD Warner Chilcott
PRS Account Warner Chilcott
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP