Effect of Udenafil on Spermatogenesis

Completed · Phase 1 · Has a placebo group

Conditions studied: Spermatogenesis, Erectile Dysfunction

In brief

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

Key facts

Study ID

NCT01230541

Run by

Warner Chilcott

People needed

239

Starts

2010-09-01

Expected to finish

2011-11-01

Last updated by the study team

2011-11-30

Who can join

Age: 25 and older, up to 64. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Warner Chilcott Investigational Site — Huntsville, Alabama, United States
• Warner Chilcott Investigational Site — Anaheim, California, United States
• Warner Chilcott Investigational Site — San Diego, California, United States
• Warner Chilcott Investigational Site — San Diego, California, United States
• Warner Chilcott Investigational Site — Tarzana, California, United States
• Warner Chilcott Investigational Site — Middlebury, Connecticut, United States
• Warner Chilcott Investigational Site — Aventura, Florida, United States
• Warner Chilcott Investigational Site — Clearwater, Florida, United States
• Warner Chilcott Investigational Site — Doral, Florida, United States
• Warner Chilcott Investigational Site — Ocala, Florida, United States
• Warner Chilcott Investigational Site — Pinellas Park, Florida, United States
• Warner Chilcott Investigational Site — Atlanta, Georgia, United States
• Warner Chilcott Investigational Site — Shreveport, Louisiana, United States
• Warner Chilcott Investigational Site — Plainsboro, New Jersey, United States
• Warner Chilcott Investigational Site — Garden City, New York, United States
• Warner Chilcott Investigational Site — Great Neck, New York, United States
• Warner Chilcott Investigational Site — Purchase, New York, United States
• Warner Chilcott Investigational Site — Williamsville, New York, United States
• Warner Chilcott Investigational Site — Cincinnati, Ohio, United States
• Warner Chilcott Investigational Site — San Antonio, Texas, United States
• Warner Chilcott Investigational Site — Webster, Texas, United States
• Warner Chilcott Investigational Site — Norfolk, Virginia, United States
• Warner Chilcott Investigational Site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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