check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

100536

ClinicalTrials.gov Identifier:

NCT00661297

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study evaluating the efficacy, safety, and reliability of Vardenafil

Trial purpose

Study to investigate the efficacy and safety of Vardenafil

Key Participants Requirements

Sex

Male

Age

18 Years
  • - Heterosexual males
    - >/= 18 years old with ED for more than six months
    - Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation
  • - 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
523
Trial Dates
June 2003 - January 2004
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Primary Outcome

  • Sexual Encounter Profile question 2 (SEP 2)
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Sexual Encounter Profile question 3 (SEP 3)
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • International Index of Erectile Function (IIEF) - EF (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 randomised, double-blind, parallel-group, placebo-controlled study evaluating the efficacy, safety, and reliability of 10mg vardenafil administered for 12 weeks compared to placebo in subjects with erectile dysfunction
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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