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OpenTrials
Completed

NCT Number: NCT00656188

Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
  • History of unresponsiveness to sildenafil
  • Stable sexual relationship for > 6 month

Exclusion criteria

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse

Placebo

Drug

Matching placebo

Primary outcomes

  1. Erectile Function domain of the International Index of Erectile Function

    Time frame: 12 weeks

  2. Sexual Encounter Profile Question 2

    Time frame: 12 weeks

  3. Sexual Encounter Profile Question 3

    Time frame: 12 weeks

Secondary outcomes

  1. Erectile Function domain scores > 26

    Time frame: 12 weeks

  2. Sexual Encounter Profile 2

    Time frame: 12 weeks

  3. Global Assessment Question

    Time frame: 12 weeks

  4. Reliability of insertion

    Time frame: 12 weeks

  5. Reliability of maintenance

    Time frame: 12 weeks

  6. Other subject diary based variables

    Time frame: 12 weeks

  7. Safety and tolerability

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Apr 10, 2008
Registry last updated
Oct 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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