check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

11520

ClinicalTrials.gov Identifier:

NCT00655590

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

25 - 64 Years
  • - 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.

  • - 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

Trial summary

Enrollment Goal
200
Trial Dates
January 2005 - June 2006
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
West Coast Clinical ResearchVan Nuys, 91405, United States
Terminated
Urology Specialists, PCWaterbury, 06708, United States
Completed
Center for Urological ResearchLa Mesa, 91942-3058, United States
Terminated
South Florida Medical ResearchAventura, 33180, United States
Completed
Tulane Medical CenterNew Orleans, 70112, United States
Completed
Harbor - UCLA Medical CenterTorrance, 90502-2004, United States
Terminated
South Coast Urological Medical GroupLaguna Hills, 92653, United States
Completed
Arizona Research Center, Inc.Phoenix, 85023, United States
Completed
Urology San Antonio Research, PASan Antonio, 78229, United States
Completed
NYU Langone Medical CenterNew York, 10016-4576, United States
Completed
University of Michigan Health SystemAnn Arbor, 48109-0330, United States
Completed
Office of Dr. Bruce Gilbert, MDGreat Neck, 11021, United States
Completed
The Male ClinicBeverly Hills, 90212, United States
Completed
The Urology GroupCincinnati, 45212-2787, United States
Completed
Scripps ClinicSan Diego, 92128, United States
Completed
Tempe Primary Care Associates, PCTempe, 85282, United States
Completed
University of MinnesotaMinneapolis, 55455, United States
Terminated
Mayo Clinic - RochesterRochester, 55905, United States

Primary Outcome

  • 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
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Mean sperm concentration
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    yes
  • Mean sperm count
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    yes
  • Sperm morphology
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    yes
  • Sperm motility
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    yes
  • Reproductive hormones
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    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
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.