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OpenTrials
Completed

NCT Number: NCT00668057

BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.

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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

22 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Hangzhou, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
  • Stable heterosexual relationship

Exclusion criteria

  • Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
  • Nitrate use
  • Other exclusion criteria apply

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

5 mg Vardenafil orally 1 hour prior to sexual intercourse

Placebo

Drug

5 mg matching placebo

Primary outcomes

  1. Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15

    Time frame: 12 weeks

Secondary outcomes

  1. Global Assessment Questionnaire

    Time frame: 12 weeks

  2. Erectile Function domain score of the International Index of Erectile Function

    Time frame: 12 weeks

  3. Safety and tolerability

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Apr 28, 2008
Registry last updated
Mar 6, 2015

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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