check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
10893
ClinicalTrials.gov Identifier:
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
MaleAge
18 YearsTrial summary
Enrollment Goal
614Trial Dates
December 2003 - June 2004Phase
Phase 3Could I Receive a placebo
NoProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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Withdrawn | Oulu, FI-90100, Finland | |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Withdrawn | Skövde, 541 30, Sweden | |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Withdrawn | Helsinki, 00100, Finland | |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Withdrawn | Stockholm, 113 64, Sweden | |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Withdrawn | Oslo, 0272, Norway | |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Withdrawn | BRUXELLES - BRUSSEL, 1070, Belgium | |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Withdrawn | Helsinki, 00180, Finland | |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Withdrawn | Milano, 20142, Italy | |
Withdrawn | Monterrey, 66260, Mexico | |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Withdrawn | Borås, 503 32, Sweden | |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 groupdate_rangeTime Frame:4 weeksenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Sexual encounter profile question 2date_rangeTime Frame:4 weeksenhanced_encryptionnoSafety Issue:
- Hardness of erectiondate_rangeTime Frame:4 weeksenhanced_encryptionnoSafety Issue:
- Other diary based variablesdate_rangeTime Frame:4 weeksenhanced_encryptionnoSafety Issue:
- Safety and tolerabilitydate_rangeTime Frame:4 weeksenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2