Trial Condition(s):
Erectile Dysfunction
Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia (LUTECIA)
Bayer Identifier:
10893
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site ROESELAERE, Belgium, 8800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santa Fe de Bogotá, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Weiden, Germany, 92637 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site A Coruña, Spain, 15006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cape Town, South Africa, 7500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zaragoza, Spain, 50009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9112001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moelv, Norway, 2390 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lima, Peru, 33 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barranquilla, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13465 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 64239 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site México, D.F., Mexico, 14000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Den Bosch, Netherlands, 5223 GV | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lima, Peru, 27 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Medellín, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13347 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durango, Mexico, 34000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site de Bilt, Netherlands, 3731 DN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site George, South Africa, 6530 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site EDEGEM, Belgium, 2650 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Castellón de la Plana, Spain, 12004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0083 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Den Haag, Netherlands, 2574 GT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sarpsborg, Norway, 1700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Callao, Peru, 2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santafe de Bogotá, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vigo, Spain, 36211 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 52482 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIJVERDAL, Netherlands, 7442 LS | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trondheim, Norway, 7030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newcastle, South Africa, 2940 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81925 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site México, D. F., Mexico | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durban, South Africa, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Freiburg, Germany, 79106 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Juan de Alicante, Spain, 03550 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mönchengladbach, Germany, 41061 | Status Completed | Contact Us: E-mail: [email protected]hcare.com Phone: Not Available |
Locations Investigative Site Málaga, Spain, 29010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durban, South Africa, 3630 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20354 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durban, South Africa, 4091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Catania, Italy, 95124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2193 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perugia, Italy, 06132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Königsbrunn, Germany, 86343 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pietermaritzburg, South Africa, 3200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osnabrück, Germany, 49076 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Marburg, Germany, 35039 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 80333 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13125 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cape Town, South Africa, 7800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stuttgart, Germany, 70372 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil groupTimeframe: 4 weeks
Secondary Outcome
- Sexual encounter profile question 2Timeframe: 4 weeks
- Hardness of erectionTimeframe: 4 weeks
- Other diary based variablesTimeframe: 4 weeks
- Safety and tolerabilityTimeframe: 4 weeks
Additional Information
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