Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function

Completed · Phase 4 · Has a placebo group

Conditions studied: Erectile Dysfunction

In brief

Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function

Key facts

Study ID

NCT00655590

Run by

Bayer

People needed

200

Starts

2005-01-01

Expected to finish

2006-06-01

Last updated by the study team

2014-12-30

Who can join

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

You may qualify if…

• Healthy male subjects or men with ED aged 25 - 64
• Baseline sperm conc. of > 20 mio / ml- Normal World Health Organization A+B+C sperm mortality > 50%- Normal sperm morphology (WHO, 1992 manual criteria) > 30% and - 1.0 mL ejaculate volume at each of the 3 analyses during the screening phase.

You may not qualify if…

• Presence of any psychological or physiological abnormalities that in the opinion of the Investigator would significantly impair sexual performance or ability to provide semen samples according to the protocol- Spinal cord injury
• History of surgical prostatectomy
• Other exclusion criteria apply according to US Product Information

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — La Mesa, California, United States
• Study site — Laguna Hills, California, United States
• Study site — San Diego, California, United States
• Study site — Torrance, California, United States
• Study site — Van Nuys, California, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Aventura, Florida, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Rochester, Minnesota, United States
• Study site — Great Neck, New York, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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