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

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ClinicalTrials.gov Identifier: NCT00668109
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 614 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2003
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668109


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00668109    
Other Study ID Numbers: 10893
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Erectile Dysfunction
Diabetes mellitus
Hypertension
Hyperlipidemia
Vardenafil
Additional relevant MeSH terms:
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Erectile Dysfunction
Hypertension
Hyperlipidemias
Hyperlipoproteinemias
Vascular Diseases
Cardiovascular Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Dyslipidemias
 Lipid Metabolism Disorders
Metabolic Diseases
Tadalafil
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents