check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

100539

ClinicalTrials.gov Identifier:

NCT00668005

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluating the efficacy and safety of vardenafil in subjects with erectile dysfunction and hypertension

Trial purpose

Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure

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,
    - Arterial hypertension adequately controlled
    - 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
388
Trial Dates
February 2003 - September 2003
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation

Primary Outcome

  • Sexual Encounter Profile (SEP), questions 2 and 3
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • International Index of Erectile Function (IIEF) - EF (Erectile Function) domain
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Global Assessment Questionnaire (GAQ)
    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 randomized, double-blind, parallel-group, plac-controlled study evaluating the efficacy and safety of vardenafil administration for 12 weeks in a flexible-dose regimen compared to placebo in men with arterial hypertension and 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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