check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

10473

ClinicalTrials.gov Identifier:

NCT00654680

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluating the efficacy and safety of vardenafil in patients erectile dysfunction solely secondary to spinal cord injury

Trial purpose

Investigate efficacy and safety of Vardenafil in patients with spinal cord injury

Key Participants Requirements

Sex

Male

Age

18 Years
  • - Males ≥18 years with erectile dysfunction (ED) solely as a result of
    traumatic spinal cord injury (SCI) for ≥6 months with demonstrated 50% failure in intercourse attempts during the
    4-week run-in period.
    - Stable heterosexual relationship for at least 1 month.
  • - Subjects with unstable medical or psychiatric conditions or using prohibited concomitant medications
    - Primary hypoactive sexual desire
    - History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
    - Nitrate therapy
    - Other exclusion criteria apply according to US Product Information or Summary of Product Characteristics

Trial summary

Enrollment Goal
418
Trial Dates
October 2002 - January 2004
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
United Kingdom
Completed
United States

Primary Outcome

  • International Index of Erectile Function-Erectile Function domain
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Sexual Encounter Profile Question 2
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Sexual Encounter Profile Question 3
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Other diary based variables
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Safety and tolerability
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

A rand, db, parallel-group, plac-controlled study evaluating the efficacy and safety of vardenafil administered for 12 weeks in a flexible-dose regimen compared to plac in subjects with ED solely secondary to traumatic spinal cord injury
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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