Erectile Dysfunction, Spermatogenesis
Conditions
Keywords
Semen characteristics, Erectile Dysfunction
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)
Interventions
DRUGPlacebo
Daily, oral tablet
DRUGUdenafil
Daily tablet
Sponsors
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
25 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sperm Concentration Reduction greater than or equal to 50% at Week 26 | 26 weeks | Percentage of Subjects with greater than or equal to 50% decrease from baseline in sperm concentration at 26 weeks |
Countries
United States
Outcome results
None listed