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 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 Reproductive hormones 24 weeks