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OpenTrials
Completed

NCT Number: NCT00662441

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

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).

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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 4

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
  • Erectile Dysfunction

Exclusion criteria

  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy
  • Other exclusion criteria apply according to the Summary of Product Characteristics

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

10mg taken 1 hours before sexual intercourse

Primary outcomes

  1. International Index of Erectile Function- Erectile Function domain

    Time frame: 8 weeks

Secondary outcomes

  1. Global Assessment Questionnaire (GAQ)

    Time frame: 8 weeks

  2. Safety and tolerability

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Open-Label, Multi-Centre, Study of Levitra 10 mg Once a Day in Males With Erectile Dysfunction Was Carried Out in Four Centres Namely Lagos, Port Harcourt, Enuge and Maiduguri at Their University Teaching Hospitals

Important dates

Study start
2003
Study completion
2004
First posted
Apr 21, 2008
Registry last updated
Jun 22, 2009

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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