check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

11575

ClinicalTrials.gov Identifier:

NCT00663728

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessment of duration of erection with vardenafil 10 mg

Trial purpose

This study assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting, as compared to placebo (dummy medication with no pharmacological activity), on the duration of erection from the moment when the patient perceived his erection to be hard enough for penetration until withdrawal from the partner's vagina leading to successful completion which may or may not have included ejaculation. The patient used the stopwatch for the above assessments. The efficacy of oral ED treatments is measured by questionnaires and patient diaries.

Key Participants Requirements

Sex

Male

Age

18 - 64 Years
  • - Males with erectile dysfunction- Stable heterosexual relationship
  • - Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months nitrate use

Trial summary

Enrollment Goal
201
Trial Dates
September 2004 - April 2005
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Primary Outcome

  • Effect of vardenafil on the duration of erection
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Perception of erection to be hard enough for penetration
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    no

Trial design

A randomized, double-blind, crossover study to evaluate the duration of erection following vardenafil (10mg) administration for four weeks in a fixed dose regimen compared to placebo in males with ED
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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