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OpenTrials
Completed

NCT Number: NCT00661297

Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil

Study to investigate the efficacy and safety of Vardenafil

Completed

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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 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

10 mg Vardenafil to be taken 1 h prior to sexual attempt

Placebo

Drug

Matching placebo

Primary outcomes

  1. Sexual Encounter Profile question 2 (SEP 2)

    Time frame: 12 weeks

Secondary outcomes

  1. Sexual Encounter Profile question 3 (SEP 3)

    Time frame: 12 weeks

  2. International Index of Erectile Function (IIEF) - EF (Erectile Function) domain

    Time frame: 12 weeks

  3. Safety and Tolerability

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Apr 18, 2008
Registry last updated
Dec 2, 2014

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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