Study Completed

Erectile Dysfunction

Bayer Identifier:

10678

ClinicalTrials.gov Identifier:

NCT00668018

EudraCT Number:

Not Available

EU CT Number:

Not Available

Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours

Trial purpose

Assess efficacy of vardenafil within 6 hours after intake

Key Participants Requirements

Sex

Male

Age

18 Years

Trial summary

Enrollment Goal

887

Trial Dates

January 2003 - October 2003

Phase

Phase 3

Could I Receive a placebo

Products

Levitra (Vardenafil, BAY38-9456)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Salzburg, 5020, Austria
Completed		Leipzig, 04179, Germany
Completed		St. Pölten, 3100, Austria
Withdrawn		Berlin, 10827, Germany
Completed		Mistelbach, 2130, Austria
Completed		Kleinmachnow, 14532, Germany
Completed		Leoben, 8700, Austria
Completed		Berlin, 13465, Germany
Completed		Wien, 1021, Austria
Completed		Dresden, 01307, Germany
Completed		Linz, 4010, Austria
Completed		Meißen, 01662, Germany
Completed		Wien, 1130, Austria
Completed		Dresden, 01157, Germany
Completed		Bregenz, 6900, Austria
Withdrawn		Magdeburg, 39104, Germany
Completed		Salzburg, 5020, Austria
Completed		Wolfen, 06766, Germany
Completed		Wien, 1090, Austria
Completed		Berlin, 13053, Germany
Completed		Meißen, 01662, Germany
Completed		Weida, 07570, Germany
Completed		Berlin, 10713, Germany
Completed		Wilkau-Haßlau, 08112, Germany
Completed		Schwerin, 19053, Germany
Completed		Rostock, 18107, Germany
Completed		Neubrandenburg, 17033, Germany
Completed		Berlin, 13347, Germany
Completed		Berlin, 14197, Germany
Completed		Chemnitz, 09119, Germany
Completed		Dresden, 01217, Germany
Completed		Halle, 06132, Germany
Completed		Henningsdorf, 16761, Germany
Withdrawn		Berlin, 13086, Germany
Completed		Naumburg, 06618, Germany
Completed		Berlin, 13409, Germany
Withdrawn		Schkeuditz, 04435, Germany
Completed		Zwickau, 08060, Germany
Completed		Dessau, 06844, Germany
Completed		Cottbus, 03050, Germany
Completed		Berlin, 10249, Germany
Completed		Berlin, 12043, Germany
Completed		Berlin, 12107, Germany
Completed		Gardelegen, 39638, Germany
Withdrawn		Demmin, 17109, Germany
Withdrawn		Görlitz, 02826, Germany
Completed		Radebeul, 01445, Germany
Completed		Berlin, 14197, Germany
Completed		Forst, 03149, Germany
Completed		Berlin, 12435, Germany
Completed		Berlin, 12247, Germany
Withdrawn		Erfurt, 99086, Germany
Completed		Gotha, 99867, Germany
Completed		Potsdam, 14480, Germany
Completed		Hagenow, 19230, Germany
Completed		Berlin, 12435, Germany
Withdrawn		Halberstadt, 38820, Germany
Completed		Frankfurt, 15230, Germany
Completed		Waltershausen, 99880, Germany
Completed		Jena, 07747, Germany
Completed		Gera, 07546, Germany
Completed		Potsdam, 14480, Germany
Completed		Aschersleben, 06449, Germany
Completed		Görlitz, 02827, Germany
Completed		Stadtallendorf, 35260, Germany
Completed		Lübeck, 23552, Germany
Withdrawn		Hamburg, 22399, Germany
Completed		Rendsburg, 24768, Germany
Completed		Hannover, 30161, Germany
Completed		Tostedt, 21423, Germany
Completed		Braunschweig, 38102, Germany
Completed		Delmenhorst, 27753, Germany
Completed		Neustadt, 31535, Germany
Completed		Ganderkesee, 27777, Germany
Completed		Bremervörde, 27432, Germany
Completed		Delmenhorst, 27753, Germany
Completed		Kiel, 24103, Germany
Completed		Bad Zwischenahn, 26160, Germany
Completed		Hannover, 30161, Germany
Completed		Braunschweig, 38102, Germany
Completed		Lüchow, 29439, Germany
Completed		Bad Schwartau, 23611, Germany
Withdrawn		Hamburg, 22767, Germany
Withdrawn		Aurich, 26603, Germany
Completed		Achim, 28832, Germany
Completed		Peine, 31226, Germany
Completed		Wolfsburg, 38440, Germany
Withdrawn		Kappeln, 24376, Germany
Completed		Wedel, 22880, Germany
Completed		Hamburg, 20095, Germany
Completed		Wismar, 23970, Germany
Completed		Lilienthal, 28865, Germany
Withdrawn		Elmshorn, 25335, Germany
Completed		Schwerin, 19057, Germany
Completed		Schwerte, 58239, Germany
Completed		Frankenthal, 67227, Germany
Completed		Gelsenkirchen, 45879, Germany
Completed		Duisburg, 47051, Germany
Completed		Sankt Ingbert, 66386, Germany
Completed		Frankfurt, 60385, Germany
Withdrawn		Offenbach, 63067, Germany
Completed		Schwelm, 58332, Germany
Completed		Bonn, 53119, Germany
Completed		Neuss, 41460, Germany
Completed		Pirmasens, 66953, Germany
Completed		Krefeld, 47803, Germany
Completed		Köln, 50935, Germany
Completed		Kleve, 47533, Germany
Completed		Aachen, 52062, Germany
Completed		Heidelberg, 69126, Germany
Withdrawn		Aachen, 52078, Germany
Completed		Köln, 51145, Germany
Completed		Koblenz, 56068, Germany
Withdrawn		Frankfurt, 60594, Germany
Completed		Regensburg, 93055, Germany
Completed		Wuppertal, 42329, Germany
Completed		Herrenberg, 71083, Germany
Completed		Wuppertal, 42103, Germany
Completed		Fulda, 36037, Germany
Completed		Witten, 58452, Germany
Completed		Homburg, 66424, Germany
Completed		Kaarst, 41564, Germany
Completed		Olpe, 57462, Germany
Completed		Nieder-Olm, 55268, Germany
Completed		Wiesbaden, 65183, Germany
Completed		Delbrück, 33129, Germany
Completed		Essen, 45355, Germany
Completed		Trier, 54290, Germany
Completed		Duisburg, 47179, Germany
Completed		Düren, 52349, Germany
Completed		Bad Neuenahr-Ahrweiler, 53474, Germany
Completed		Wetzlar, 35576, Germany
Completed		Gelsenkirchen, 45894, Germany
Completed		Reinheim, 64354, Germany
Completed		Hattersheim, 65795, Germany
Completed		Vallendar, 56179, Germany
Completed		Aschaffenburg, 63739, Germany
Completed		Leverkusen, 51373, Germany
Completed		Kamp-Lintfort, 47475, Germany
Completed		Sögel, 49751, Germany
Completed		Brühl, 50321, Germany
Completed		Herford, 32052, Germany
Completed		Dortmund, 44359, Germany
Withdrawn		Miltenberg, 63897, Germany
Completed		Hanau, 63450, Germany
Completed		Köln, 50935, Germany
Completed		Dortmund, 44137, Germany
Completed		Herne, 44623, Germany
Completed		Rimbach, 64668, Germany
Withdrawn		Kaufungen, 34260, Germany
Completed		Dierdorf, 56269, Germany
Completed		Aachen, 52062, Germany
Completed		Ludwigshafen, 67059, Germany
Completed		Hennef, 53773, Germany
Completed		Offenbach, 63067, Germany
Withdrawn		Wiesloch, 69168, Germany
Completed		Minden, 32423, Germany
Completed		Maintal, 63477, Germany
Completed		Gießen, 35390, Germany
Completed		Borken, 46325, Germany
Completed		Münster, 48143, Germany
Completed		Homburg, 66424, Germany
Completed		Essen, 45329, Germany
Completed		Bochum, 44866, Germany
Completed		Bocholt, 46399, Germany
Completed		Mülheim, 45475, Germany
Completed		Oelde, 59302, Germany
Completed		Düren, 52349, Germany
Withdrawn		Merzig, 66663, Germany
Completed		Siegen, 57072, Germany
Completed		Leverkusen, 51373, Germany
Completed		Krefeld, 47803, Germany
Completed		Krefeld, 47803, Germany
Completed		Mülheim, 45481, Germany
Completed		Wiesbaden, 65197, Germany
Completed		Warendorf, 48231, Germany
Completed		Mannheim, 68307, Germany
Completed		Hamm, 59065, Germany
Completed		Berlin, 13347, Germany
Completed		Naumburg, 06618, Germany
Completed		München, 80335, Germany
Completed		Gaggenau, 76571, Germany
Completed		Pforzheim, 75172, Germany
Completed		Eggenfelden, 84307, Germany
Completed		Weiden, 92637, Germany
Completed		Ravensburg, 88212, Germany
Completed		Nürnberg, 90443, Germany
Completed		Stuttgart, 70182, Germany
Completed		Weißenburg, 91781, Germany
Completed		Künzelsau, 74653, Germany
Completed		Rheinfelden, 79618, Germany
Completed		Landshut, 84028, Germany
Completed		Herzogenaurach, 91074, Germany
Completed		Neusäß, 86356, Germany
Completed		Ulm, 89073, Germany
Completed		Günzburg, 89312, Germany
Completed		Königsbrunn, 86343, Germany
Completed		München, 80802, Germany
Completed		Hersbruck, 91217, Germany
Withdrawn		Freiburg, 79098, Germany
Completed		Wendlingen, 73240, Germany
Completed		Stuttgart, 70173, Germany
Completed		Hechingen, 72379, Germany
Completed		Überlingen, 88662, Germany
Completed		Bamberg, 96052, Germany
Completed		Landshut, 84028, Germany
Completed		Schwabach, 91126, Germany
Completed		Augsburg, 86150, Germany
Completed		Dachau, 85221, Germany
Completed		Reutlingen, 72764, Germany
Completed		Weiden, 92637, Germany
Completed		Heilbronn, 74072, Germany
Completed		Nürnberg, 90482, Germany
Completed		Königsbrunn, 86343, Germany
Completed		Freiburg, 79098, Germany
Completed		München, 81241, Germany
Withdrawn		Radolfzell, 78315, Germany
Completed		Karlsruhe, 76137, Germany
Completed		Straubing, 94315, Germany
Withdrawn		Singen, 78224, Germany
Completed		Nagold, 72202, Germany
Completed		Waldshut-Tiengen, 79761, Germany
Withdrawn		Buchen, 74722, Germany
Completed		Landau, 94405, Germany
Completed		Holzkirchen, 83607, Germany
Completed		Schongau, 86956, Germany
Completed		Naila, 95119, Germany
Completed		Stuttgart, 70372, Germany
Completed		Starnberg, 82319, Germany
Completed		Trostberg, 83308, Germany
Withdrawn		Gaggenau, 76571, Germany
Completed		Regensburg, 93055, Germany
Completed		Bergisch Gladbach, 51427, Germany

Primary Outcome

Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake
Time Frame:
12 weeks
Safety Issue:
no

Secondary Outcome

International Index of Erectile Function
Time Frame:
12 weeks
Safety Issue:
no
Global Assessment Question (GAQ)
Time Frame:
12 weeks
Safety Issue:
no
Other diary responses
Time Frame:
12 weeks
Safety Issue:
no
General Safety
Time Frame:
12 weeks
Safety Issue:
yes

Trial design

An Open-label, Multicenter Study to Assess Safety, Tolerability, Efficacy and Impact on Quality of Life of Vardenafil 10mg in Patients With Erectile Dysfunction Within a Time Window of up to 6 Hours After Intake of Study Drug

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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