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Completed

NCT Number: NCT00668109

Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia

Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia

Completed

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Key information

Conditions

Erectile Dysfunction Cardiovascular Diseases Diabetes Mellitus Dyslipidemias Endocrine System Diseases Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Hyperlipidemias Hypertension Lipid Metabolism Disorders Male Urogenital Diseases Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases 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

Primary location

Bruxelles - Brussel, Belgium

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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- Medical history / diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia Exclusion Criteria:- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use- Other exclusion criteria apply according to Summary of Product Characteristics

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

10 mg one hour prior to sexual intercourse

Tadalafil

Drug

10 mg taken approximately 24 hours prior to sexual intercourse

Primary outcomes

  1. Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group

    Time frame: 4 weeks

Secondary outcomes

  1. Sexual encounter profile question 2

    Time frame: 4 weeks

  2. Hardness of erection

    Time frame: 4 weeks

  3. Other diary based variables

    Time frame: 4 weeks

  4. Safety and tolerability

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Randomized, Open-label, Multi-center, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil in Comparison to Tadalafil in Males With Erectile Dysfunction and a Diagnosis of Diabetes, Hypertension or Hyperlipidemia

Acronym: LUTECIA

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
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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