Clinical Proof-of-concept Study for the Combination BAY60-4552 / Vardenafil for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 Inhibitors

PHASE2CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Erectile Dysfunction
Interventions
DRUG

BAY60-4552 plus Vardenafil

Treatment with 3 tablets once daily for 4 weeks (Vardenafil 10 mg plus BAY60-4552 1.0 mg)

DRUG

Vardenafil

Treatment with 3 tablets once daily for 4 weeks (Vardenafil 20 mg)

DRUG

Placebo

Treatment with 3 tablets once daily for 4 weeks (Placebo)

Trial Locations (36)

20100

Turku

20132

Milan

20246

Hamburg

20354

Hamburg

28023

Aravaca

28222

Majadahonda

29007

Málaga

30000

Nîmes

35039

Marburg

45468

Mülheim

49076

Osnabrück

50141

Florence

56068

Koblenz

59000

Lille

69437

Lyon

73011

Chambéry

80131

Napoli

90100

Oulu

92380

Garches

92637

Weiden

FIN-33520

Tampere

06200

Nice

04105

Leipzig

04109

Leipzig

00133

Roma

9713 GZ

Groningen

2333 ZA

Leiden

2545 CH

The Hague

08003

Barcelona

08036

Barcelona

633 40

Eskilstuna

405 45

Gothenburg

302 45

Halmstad

554 66

Jönköping

581 85

Linköping

141 86

Stockholm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY