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

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”

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

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • 20 mg daily dosing
• Drug: Sildenafil
  • 100 mg daily dosing
• Drug: Placebo
  • Matching placebos

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Active Comparator: Arm 2
• Placebo Comparator: Arm 3

Primary Measures

• 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
  • Time Frame: 24 weeks
    Safety Issue?: Yes

Secondary Measures

• Mean sperm concentration
  • Time Frame: 24 weeks
    Safety Issue?: Yes
• Mean sperm count
  • Time Frame: 24 weeks
    Safety Issue?: Yes
• Sperm morphology
  • Time Frame: 24 weeks
    Safety Issue?: Yes
• Sperm motility
  • Time Frame: 24 weeks
    Safety Issue?: Yes
• Reproductive hormones
  • Time Frame: 24 weeks
    Safety Issue?: Yes
• 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
  • Time Frame: 24 weeks
    Safety Issue?: 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 exclusion criteria apply according to US Product Information

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00655590

Study ID Number: 11520

ClinicalTrials.gov Identifier: NCT00655590

Health Authority: United States: Food and Drug Administration

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