Effect of Udenafil on Spermatogenesis
Phase 1
Completed
- Conditions
- SpermatogenesisErectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT01230541
- Lead Sponsor
- Warner Chilcott
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 239
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Udenafil Udenafil Udenafil daily tablet
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Warner Chilcott Investigational Site
🇺🇸Spokane, Washington, United States