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OpenTrials
Completed

NCT Number: NCT00668005

Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction and Hypertension

Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure

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Key information

Conditions

Erectile Dysfunction Cardiovascular Diseases Genital Diseases Genital Diseases, Male Hypertension Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Vascular 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

  • Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
  • Arterial hypertension adequately controlled
  • Stable sexual relationship for > 6 month

Exclusion criteria

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

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

5mg, 10mg or 20mg taken 1h before sexual intercourse

Placebo

Drug

Matching placebo

Primary outcomes

  1. Sexual Encounter Profile (SEP), questions 2 and 3

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: 12 weeks

  2. Global Assessment Questionnaire (GAQ)

    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 Randomized, Double-blind, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administration for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Men With Arterial Hypertension and Erectile Dysfunction

Important dates

Study start
2003
Study completion
2003
First posted
Apr 28, 2008
Registry last updated
Dec 16, 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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