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OpenTrials
Completed

NCT Number: NCT00663728

Assessment of Duration of Erection With Vardenafil 10 mg

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.

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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–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

- 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

10mg Vardenafil taken orally 1 hour prior to sexual intercourse

Placebo

Drug

Matching placebo

Primary outcomes

  1. Effect of vardenafil on the duration of erection

    Time frame: 4 weeks

Secondary outcomes

  1. Perception of erection to be hard enough for penetration

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Apr 22, 2008
Registry last updated
Dec 30, 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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