Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function
Phase 4
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Registration Number
- NCT00655590
- Lead Sponsor
- Bayer
- Brief Summary
Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 200
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Levitra (Vardenafil, BAY38-9456) - Arm 3 Placebo - Arm 2 Sildenafil -
- Primary Outcome Measures
Name Time Method Proportion of vardenafil subjects with a 50% or greater decrease from baseline in mean sperm concentration at 6 months (LOCF), compared to placebo after repeated use 24 weeks
- Secondary Outcome Measures
Name Time Method Mean sperm concentration 24 weeks Mean sperm count 24 weeks Sperm morphology 24 weeks Sperm motility 24 weeks Reproductive hormones 24 weeks Proportion of sildenafil subjects with a 50% or greater decrease from baseline in mean sperm concentration at 6 months (LOCF), compared to placebo and vardenafil after repeated use 24 weeks