Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving ED

PHASE3CompletedINTERVENTIONAL
Enrollment

628

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

September 30, 2007

Study Completion Date

September 30, 2007

Conditions
Erectile DysfunctionSexual Dysfunction, Physiological
Interventions
DRUG

Levitra (Vardenafil, BAY38-9456)

9 months DAILY dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication

DRUG

Levitra (Vardenafil, BAY38-9456)

9 months PRN dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication

DRUG

Placebo

9 months placebo (double blind)2 months single-blind placebo wash-out period (subject only is blinded)2 months open-label PRN treatment with active medication

Trial Locations (86)

1000

Bruxelles - Brussel

1200

Bruxelles - Brussel

2193

Johannesburg

2390

Moelv

2650

Edegem

3000

Leuven

3010

Bern

3103

Tønsberg

3200

Pietermaritzburg

3500

Hasselt

4000

Liège

5020

Salzburg

7505

Cape Town

8001

Cape Town

8036

Graz

12601

Poughkeepsie

16132

Genova

17604

Lancaster

20127

Milan

20132

Milan

20246

Hamburg

28046

Madrid

29010

Málaga

30000

Nîmes

33100

Tampere

34149

Trieste

36211

Vigo

38118

Braunschweig

39202

Jackson

44137

Dortmund

44627

Herne

46009

Valencia

46026

Valencia

47130

Jeffersonville

49076

Osnabrück

50139

Florence

50309

Des Moines

51375

Leverkusen

59037

Lille

63069

Offenbach

68167

Mannheim

69230

Saint-Genis-Laval

69437

Lyon

70124

Bari

72076

Tübingen

73104

Oklahoma City

80131

Napoli

81377

München

81675

München

84200

Carpentras

90220

Oulu

92637

Weiden

92653

Laguna Hills

99202

Spokane

45212-2787

Cincinnati

43214-1419

Columbus

02904

Providence

T2V 4R6

Calgary

T6G 2C8

Edmonton

L4M 7G1

Barrie

N6A 4V2

London

L6H 3P1

Oakville

M4N 3M5

Toronto

G7H 4A3

Chicoutimi

J1H 5N4

Fleurimont

E2L 3J8

St. John's

V8R 6T9

Victoria

FI-90100

Oulu

2333 ZA

Leiden

6525 GA

Nijmegen

3015 GD

Rotterdam

0083

Pretoria

08025

Barcelona

08036

Barcelona

413 45

Gothenburg

417 17

Gothenburg

301 85

Halmstad

221 85

Lund

541 30

Skövde

721 89

Västerås

BA1 3NG

Bath

BS10 5NB

Bristol

SL2 4HL

Slough

W6 8RF

London

M20 4BX

Manchester

TA1 5DA

Taunton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY