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OpenTrials
Completed

NCT Number: NCT00668018

Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours

Assess efficacy of vardenafil within 6 hours after intake

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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

  • Age: 18 years and older
  • Males with erectile dysfunction
  • Stable heterosexual relationship

Exclusion criteria

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

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

Vardenafil 10mg orally on demand prior to intercourse

Primary outcomes

  1. Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake

    Time frame: 12 weeks

Secondary outcomes

  1. International Index of Erectile Function

    Time frame: 12 weeks

  2. Global Assessment Question (GAQ)

    Time frame: 12 weeks

  3. Other diary responses

    Time frame: 12 weeks

  4. General Safety

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

An Open-label, Multicenter Study to Assess Safety, Tolerability, Efficacy and Impact on Quality of Life of Vardenafil 10mg in Patients With Erectile Dysfunction Within a Time Window of up to 6 Hours After Intake of Study Drug

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Apr 28, 2008
Registry last updated
Dec 23, 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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