Status:
COMPLETED
Effect of Udenafil on Spermatogenesis
Lead Sponsor:
Warner Chilcott
Conditions:
Spermatogenesis
Erectile Dysfunction
Eligibility:
MALE
25-64 years
Phase:
PHASE1
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)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT01230541
Start Date
September 1 2010
End Date
November 1 2011
Last Update
November 30 2011
Active Locations (23)
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1
Warner Chilcott Investigational Site
Huntsville, Alabama, United States, 35801
2
Warner Chilcott Investigational Site
Anaheim, California, United States, 92801
3
Warner Chilcott Investigational Site
San Diego, California, United States, 92103
4
Warner Chilcott Investigational Site
San Diego, California, United States, 92120