Back to resultsAssessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia (LUTECIA)
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Levitra (Vardenafil, BAY38-9456)
Tadalafil
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Diabetes mellitus, Hypertension, Hyperlipidemia, Vardenafil
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
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
Secondary Outcome Measures
Sexual encounter profile question 2
Hardness of erection
Other diary based variables
Safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00668109
Brief Title
Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia
Acronym
LUTECIA
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 Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile Dysfunction, Diabetes mellitus, Hypertension, Hyperlipidemia, Vardenafil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
614 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
10 mg one hour prior to sexual intercourse
Intervention Type
Drug
Intervention Name(s)
Tadalafil
Intervention Description
10 mg taken approximately 24 hours prior to sexual intercourse
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Sexual encounter profile question 2
Time Frame
4 weeks
Title
Hardness of erection
Time Frame
4 weeks
Title
Other diary based variables
Time Frame
4 weeks
Title
Safety and tolerability
Time Frame
4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Bruxelles - Brussel
ZIP/Postal Code
1070
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
City
Barranquilla
Country
Colombia
City
Bogotá
Country
Colombia
City
Medellín
Country
Colombia
City
Santa Fé de Bogotá
Country
Colombia
City
Santafe de Bogotá
Country
Colombia
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
City
Oulu
ZIP/Postal Code
90100
Country
Finland
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70372
Country
Germany
City
Königsbrunn
State/Province
Bayern
ZIP/Postal Code
86343
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
80333
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81925
Country
Germany
City
Weiden
State/Province
Bayern
ZIP/Postal Code
92637
Country
Germany
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35039
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
City
Osnabrück
State/Province
Niedersachsen
ZIP/Postal Code
49076
Country
Germany
City
Westerstede
State/Province
Niedersachsen
ZIP/Postal Code
26655
Country
Germany
City
Mönchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41061
Country
Germany
City
Berlin
ZIP/Postal Code
13125
Country
Germany
City
Berlin
ZIP/Postal Code
13347
Country
Germany
City
Berlin
ZIP/Postal Code
13465
Country
Germany
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
City
Catania
ZIP/Postal Code
95124
Country
Italy
City
Milano
ZIP/Postal Code
20123
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Milano
ZIP/Postal Code
20142
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Perugia
ZIP/Postal Code
06126
Country
Italy
City
Pisa
ZIP/Postal Code
56126
Country
Italy
City
Iguala
State/Province
Guerrero
ZIP/Postal Code
40000
Country
Mexico
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
66260
Country
Mexico
City
Durango
ZIP/Postal Code
34000
Country
Mexico
City
México, D. F.
ZIP/Postal Code
06700
Country
Mexico
City
México, D.F.
ZIP/Postal Code
14050
Country
Mexico
City
México, D.F.
ZIP/Postal Code
14080
Country
Mexico
City
Nijverdal
ZIP/Postal Code
7442 LS
Country
Netherlands
City
Utrecht
ZIP/Postal Code
3514 AB
Country
Netherlands
City
Moelv
ZIP/Postal Code
2390
Country
Norway
City
Oslo
ZIP/Postal Code
0272
Country
Norway
City
Sarpsborg
ZIP/Postal Code
1700
Country
Norway
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
City
Callao
ZIP/Postal Code
CALLAO 2
Country
Peru
City
Lima
ZIP/Postal Code
33
Country
Peru
City
Lima
ZIP/Postal Code
LIMA 27
Country
Peru
City
George
State/Province
Eastern Cape
ZIP/Postal Code
6530
Country
South Africa
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0083
Country
South Africa
City
Pietermaritzburg
State/Province
Kwa Zulu Natal
ZIP/Postal Code
3200
Country
South Africa
City
Newcastle
State/Province
Kwa Zulu-Natal
ZIP/Postal Code
2940
Country
South Africa
City
Durban
State/Province
KwaZulu Natal
ZIP/Postal Code
4091
Country
South Africa
City
Durban
State/Province
KwaZulu- Natal
ZIP/Postal Code
4000
Country
South Africa
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
3630
Country
South Africa
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7800
Country
South Africa
City
San Juan de Alicante
State/Province
Alicante
ZIP/Postal Code
03550
Country
Spain
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36211
Country
Spain
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
City
Castellón de la Plana
ZIP/Postal Code
12004
Country
Spain
City
Málaga
ZIP/Postal Code
29010
Country
Spain
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
City
Borås
ZIP/Postal Code
503 32
Country
Sweden
City
Skövde
ZIP/Postal Code
541 30
Country
Sweden
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia
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