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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 24, 2008
Last updated: October 9, 2013
Last verified: October 2013

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:

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
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
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


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

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 identifier: NCT00668109

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

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT00668109     History of Changes
Other Study ID Numbers: 10893
Study First Received: April 24, 2008
Last Updated: October 9, 2013
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

Additional relevant MeSH terms:
Erectile Dysfunction
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses processed this record on April 16, 2014