check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

100541

ClinicalTrials.gov Identifier:

NCT00681772

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of the safety and efficacy of Vardenafil in subjects with Erectile Dysfunction

Trial purpose

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.

Key Participants Requirements

Sex

Male

Age

18 Years
  • - Men >/= 18 years of age,
    - ED 6 months or longer
    - 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
    - Other exclusion criteria apply according to the Summary of Product Characteristics

Trial summary

Enrollment Goal
333
Trial Dates
March 2003 - November 2003
Phase
Phase 4
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Australia

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 and 3
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Global Assessment Question
    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

Open-label, multi-centre, study to investigate the safety, tolerability and efficacy of flexible doses of vardenafil given on demand in males with erectile dysfunction
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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