Erectile Dysfunction Clinical Trial
Official title:
A Randomized, Double-blind, Placebo Controlled, Parallel Arm, Multicenter Trial Assessing the Effect of Daily Treatment of Vardenafil 20 mg or Sildenafil 100 mg Compared to Placebo on Spermatogenesis
Verified date | December 2014 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function
Status | Completed |
Enrollment | 200 |
Est. completion date | June 2006 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 25 Years to 64 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | Mean sperm concentration | 24 weeks | Yes | |
Secondary | Mean sperm count | 24 weeks | Yes | |
Secondary | Sperm morphology | 24 weeks | Yes | |
Secondary | Sperm motility | 24 weeks | Yes | |
Secondary | Reproductive hormones | 24 weeks | Yes | |
Secondary | 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 | Yes |
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