Erectile Dysfunction
Conditions
Keywords
Erectile Dysfunction, Sildenafil, Vardenafil, Spermatogenesis, Sperm concentration, Sperm count, Morphology, Motility, Reproductive hormonal
Brief summary
Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function
Interventions
DRUGLevitra (Vardenafil, BAY38-9456)
20 mg daily dosing
DRUGSildenafil
100 mg daily dosing
DRUGPlacebo
Matching placebos
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
25 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Mean sperm count | 24 weeks |
| Sperm morphology | 24 weeks |
| Mean sperm concentration | 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 |
| Sperm motility | 24 weeks |
Countries
United States
Outcome results
None listed