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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00668109
First received: April 24, 2008
Last updated: June 19, 2009
Last verified: June 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Erectile Dysfunction
 Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Tadalafil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sexual encounter profile question 2 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Hardness of erection [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Other diary based variables [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 530
Study Start Date: December 2003
Study Completion Date: June 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
10 mg one hour prior to sexual intercourse
Active Comparator: Arm 2 Drug: Tadalafil
10 mg taken approximately 24 hours prior to sexual intercourse

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668109

  Show 75 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
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No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00668109     History of Changes
Other Study ID Numbers: 10893
Study First Received: April 24, 2008
Last Updated: June 19, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
South Africa: Medicines Control Council
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Netherlands: Medicines Evaluation Board (MEB)
Israel: Ministry of Health
Norway: Norwegian Medicines Agency
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Mexico: Federal Commission for Protection Against Health Risks
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Bayer:
Erectile Dysfunction
Diabetes mellitus
Hypertension
Hyperlipidemia
Vardenafil

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Erectile Dysfunction
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
 Mental Disorders
Tadalafil
Vardenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013