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OpenTrials
Completed

NCT Number: NCT00663130

Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)

Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED

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–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

  • Age between 18 and 64 years
  • Heterosexual males
  • Erectile dysfunction for more than 6 months

Exclusion criteria

  • Penile anatomical abnormalities
  • Spinal cord injury
  • History of surgical prostatectomy

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse

Tadalafil

Drug

Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse

Primary outcomes

  1. Sexual Encounter Profile Question 3 (SEP-3)

    Time frame: 4 weeks

Secondary outcomes

  1. Sexual Encounter Profile Question 2 (SEP-2)

    Time frame: 4 weeks

  2. International Index of Erectile Function

    Time frame: 4 weeks

  3. Global Confidence Question (GCQ)

    Time frame: 4 weeks

  4. Erection Quality Scale (EQS)

    Time frame: 4 weeks

  5. General Safety

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

A Randomised, Double-blind, Double-dummy, Parallel-group, Active-controlled Study Evaluating the Efficacy of Vardenafil Versus Tadalafil When Intercourse is Attempted Within 45 Minutes of Administration in Subjects With Erectile Dysfunction

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Apr 22, 2008
Registry last updated
Oct 11, 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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