check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

10893

ClinicalTrials.gov Identifier:

NCT00668109

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 Years
  • - Age: 18 years and older- Males with erectile dysfunction- Stable heterosexual relationship- Medical history / diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia
  • - 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

Trial summary

Enrollment Goal
614
Trial Dates
December 2003 - June 2004
Phase
Phase 3
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
ROESELAERE, 8800, Belgium
Completed
Santa Fe de Bogotá, Colombia
Completed
Weiden, 92637, Germany
Completed
A Coruña, 15006, Spain
Withdrawn
Oulu, FI-90100, Finland
Completed
Milano, 20132, Italy
Withdrawn
Skövde, 541 30, Sweden
Completed
Cape Town, 7500, South Africa
Completed
Zaragoza, 50009, Spain
Withdrawn
Helsinki, 00100, Finland
Completed
Jerusalem, 9112001, Israel
Completed
Milano, 20123, Italy
Completed
Moelv, 2390, Norway
Completed
Lima, 33, Peru
Withdrawn
Stockholm, 113 64, Sweden
Completed
Barranquilla, Colombia
Completed
Berlin, 13465, Germany
Completed
Tel Aviv, 64239, Israel
Completed
México, D.F., 14000, Mexico
Completed
Den Bosch, 5223 GV, Netherlands
Withdrawn
Oslo, 0272, Norway
Completed
Lima, 27, Peru
Withdrawn
BRUXELLES - BRUSSEL, 1070, Belgium
Completed
Medellín, Colombia
Completed
Berlin, 13347, Germany
Completed
Durango, 34000, Mexico
Completed
de Bilt, 3731 DN, Netherlands
Completed
George, 6530, South Africa
Completed
EDEGEM, 2650, Belgium
Completed
Castellón de la Plana, 12004, Spain
Withdrawn
Helsinki, 00180, Finland
Completed
Pretoria, 0083, South Africa
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
Haifa, 3109601, Israel
Withdrawn
Milano, 20142, Italy
Withdrawn
Monterrey, 66260, Mexico
Completed
Den Haag, 2574 GT, Netherlands
Completed
Sarpsborg, 1700, Norway
Completed
Callao, 2, Peru
Withdrawn
Borås, 503 32, Sweden
Completed
Santafe de Bogotá, Colombia
Completed
Vigo, 36211, Spain
Completed
Ramat Gan, 52482, Israel
Completed
NIJVERDAL, 7442 LS, Netherlands
Completed
Trondheim, 7030, Norway
Completed
Newcastle, 2940, South Africa
Completed
Hannover, 30625, Germany
Withdrawn
Palma de Mallorca, 07120, Spain
Withdrawn
Pisa, 56126, Italy
Completed
München, 81925, Germany
Completed
Padova, 35128, Italy
Completed
México, D. F., Mexico
Withdrawn
Santa Fé de Bogotá, Colombia
Completed
Durban, 4000, South Africa
Withdrawn
Westerstede, 26655, Germany
Completed
Freiburg, 79106, Germany
Completed
San Juan de Alicante, 03550, Spain
Completed
Mönchengladbach, 41061, Germany
Completed
Málaga, 29010, Spain
Completed
Pavia, 27100, Italy
Withdrawn
Durban, 4000, South Africa
Completed
Durban, 3630, South Africa
Completed
Hamburg, 20354, Germany
Completed
Durban, 4091, South Africa
Withdrawn
Iguala, 40000, Mexico
Withdrawn
L'Hospitalet de Llobregat, 08907, Spain
Completed
Catania, 95124, Italy
Withdrawn
México, D.F., 14250, Mexico
Completed
Johannesburg, 2193, South Africa
Completed
Perugia, 06132, Italy
Completed
Königsbrunn, 86343, Germany
Completed
Pietermaritzburg, 3200, South Africa
Completed
Osnabrück, 49076, Germany
Completed
Marburg, 35039, Germany
Completed
München, 80333, Germany
Completed
Berlin, 13125, Germany
Completed
Cape Town, 7800, South Africa
Completed
Stuttgart, 70372, Germany
Withdrawn
Belgium
Withdrawn
Belgium
Withdrawn
South Africa

Primary Outcome

  • Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Sexual encounter profile question 2
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Hardness of erection
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Other diary based variables
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Safety and tolerability
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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