check_circleStudy Completed

Erectile Dysfunction

Evaluation of efficacy and safety of Vardenafil in patients with erectile dysfunction and type 1 diabetes

Trial purpose

Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction

Key Participants Requirements

Sex

Male

Age

18 Years
  • - Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
    - Diabetes type 1
    - Stable sexual relationship for > 6 month.
  • - Primary hypoactive sexual desire
    - History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
    - Nitrate therapy

Trial summary

Enrollment Goal
318
Trial Dates
February 2003 - January 2004
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Germany

Primary 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

Secondary Outcome

  • International Index of Erectile Function - Erectile Function Domain
    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 men with diabetes mellitus type 1 and erectile dysfunction
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2