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

December 18, 2014 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

614

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles - Brussel, Belgium, 1070
      • Bruxelles - Brussel, Belgium, 1200
      • Edegem, Belgium, 2650
      • Roeselare, Belgium, 8800
  • Colombia
      • Barranquilla, Colombia
      • Bogotá, Colombia
      • Medellín, Colombia
      • Santa Fé de Bogotá, Colombia
      • Santafe de Bogotá, Colombia
  • Finland
      • Helsinki, Finland, 00100
      • Helsinki, Finland, 00180
      • Oulu, Finland, 90100
  • Germany
      • Berlin, Germany, 13347
      • Berlin, Germany, 13125
      • Berlin, Germany, 13465
      • Hamburg, Germany, 20354
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
      • Stuttgart, Baden-Württemberg, Germany, 70372
    • Bayern
      • Königsbrunn, Bayern, Germany, 86343
      • München, Bayern, Germany, 80333
      • München, Bayern, Germany, 81925
      • Weiden, Bayern, Germany, 92637
    • Hessen
      • Marburg, Hessen, Germany, 35039
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
      • Osnabrück, Niedersachsen, Germany, 49076
      • Westerstede, Niedersachsen, Germany, 26655
    • Nordrhein-Westfalen
      • Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
  • Israel
      • Haifa, Israel, 31096
      • Jerusalem, Israel, 91120
      • Tel Aviv, Israel, 64239
      • Tel Hashomer, Israel, 52621
  • Italy
      • Catania, Italy, 95124
      • Milano, Italy, 20132
      • Milano, Italy, 20142
      • Milano, Italy, 20123
      • Padova, Italy, 35128
      • Pavia, Italy, 27100
      • Perugia, Italy, 06126
      • Pisa, Italy, 56126
  • Mexico
      • Durango, Mexico, 34000
      • México, D. F., Mexico, 06700
      • México, D.F., Mexico, 14080
      • México, D.F., Mexico, 14050
    • Guerrero
      • Iguala, Guerrero, Mexico, 40000
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66260
  • Netherlands
      • Nijverdal, Netherlands, 7442 LS
      • Utrecht, Netherlands, 3514 AB
  • Norway
      • Moelv, Norway, 2390
      • Oslo, Norway, 0272
      • Sarpsborg, Norway, 1700
      • Trondheim, Norway, 7006
  • Peru
      • Callao, Peru, CALLAO 2
      • Lima, Peru, 33
      • Lima, Peru, Lima 27
  • South Africa
    • Eastern Cape
      • George, Eastern Cape, South Africa, 6530
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
      • Pretoria, Gauteng, South Africa, 0083
    • Kwa Zulu Natal
      • Pietermaritzburg, Kwa Zulu Natal, South Africa, 3200
    • Kwa Zulu-Natal
      • Newcastle, Kwa Zulu-Natal, South Africa, 2940
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4091
    • KwaZulu- Natal
      • Durban, KwaZulu- Natal, South Africa, 4000
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 3630
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7505
      • Cape Town, Western Cape, South Africa, 7800
  • Spain
      • A Coruña, Spain, 15006
      • Castellón de la Plana, Spain, 12004
      • Málaga, Spain, 29010
      • Palma de Mallorca, Spain, 07014
      • Zaragoza, Spain, 50009
    • Alicante
      • San Juan de Alicante, Alicante, Spain, 03550
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36211
  • Sweden
      • Borås, Sweden, 503 32
      • Skövde, Sweden, 541 30
      • Stockholm, Sweden, 171 76

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: Tadalafil
10 mg taken approximately 24 hours prior to sexual intercourse
Experimental: Arm 1
Drug: Levitra (Vardenafil, BAY38-9456)
10 mg one hour prior to sexual intercourse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Sexual encounter profile question 2
Time Frame: 4 weeks
4 weeks
Hardness of erection
Time Frame: 4 weeks
4 weeks
Other diary based variables
Time Frame: 4 weeks
4 weeks
Safety and tolerability
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 27, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Estimate)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 18, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10893 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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