Effect of Udenafil on Spermatogenesis

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Udenafil

Criteria

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