Trial Condition(s):

Erectile Dysfunction

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

Bayer Identifier:

14694

ClinicalTrials.gov Identifier:

NCT01168817

EudraCT Number:

2010-020122-18

Study Completed

Trial Purpose

This study examines the efficacy and safety of the combination treatment BAY60-4552 plus vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy with PDE5 (Phosphodiesterase 5) inhibitors.
Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of the study to assess the effect of PDE5 inhibitor therapy given alone.
Patients with an insufficient therapeutic response to vardenafil alone will enter the next part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3 chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone, or placebo. Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last four weeks
Patients will have to go to the clinic/hospital for 7 visits during the 8 weeks.

Inclusion Criteria
- Open-label run-in phase (first four weeks):
 -- Written informed consent signed before any study-specific procedure
 -- History of ED (Erectile Dysfunction) for at least 6 months prior to screening, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse"; the diagnosis of ED has to be confirmed by a physician
 -- Stable, heterosexual relationship for at least 6 months prior to screening
 -- Aged 18 to 64 years (inclusive) at the first screening examination
 -- History of previous use of at least 1 marketed PDE5 (Phosphodiesterase 5) inhibitor and insufficient therapeutic efficacy despite use of the highest approved dose
 - Double-blind treatment phase (last four weeks):
 -- At least 4 attempts at sexual intercourse on 4 separate days during the open-label run-in phase with use of 20 mg vardenafil approximately 1 hour before attempting intercourse 
 -- IIEF EF (International Index of Erectile Function – Erectile Function subscale) score <17
 -- At least 50% of attempts at sexual intercourse during the open-label run-in phase were unsuccessful
Exclusion Criteria
- Contraindication to use of vardenafil
 - History of prostatectomy due to prostate cancer, including nerve-sparing techniques. 
 - Concomitant use of adrenergic blockers 
 - History of spinal cord injury
 - Resting hypotension, i.e. SBP (Systolic Blood Pressure) <100 mmHg at rest
 - Moderate / severe hypertension, i.e. SBP >170 mmHg or DBP >110 mmHg at rest
 - Symptomatic orthostatic hypotension with a decrease in SBP >20 mmHg or in DBP (Diastolic Blood Pressure) >10 mmHg subsequent to change from the supine to standing position

Trial Summary

Enrollment Goal
140
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
BAY98-7081
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Praxis Hr. Prof. Dr. H. Porst

Hamburg, Germany, 20354

Status
Completed
 
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

Status
Terminated
 
Locations

Klinikum Osnabrück GmbH

Osnabrück, Germany, 49076

Status
Terminated
 
Locations

Praxis Drs. Tim Schneider /B. Schneider

Mülheim, Germany, 45468

Status
Completed
 
Locations

Praxis Hr. Dr. A. von Keitz

Marburg, Germany, 35039

Status
Completed
 
Locations

Kliniken Nordoberpfalz AG - Klinikum Weiden

Weiden, Germany, 92637

Status
Completed
 
Locations

Hopital Raymond Poincaré Garches

GARCHES, France, 92380

Status
Completed
 
Locations

CETPARP - Carolus - Lille

LILLE, France, 59000

Status
Completed
 
Locations

Hôpital Edouard Herriot - Lyon Cedex

LYON CEDEX, France, 69437

Status
Completed
 
Locations

Centre Hospitalier - Chambéry cedex

CHAMBERY CEDEX, France, 73011

Status
Completed
 
Locations

Hopital Carémeau - Nîmes

NIMES, France, 30000

Status
Completed
 
Locations

Hôpital Pasteur - Nice

NICE, France, 06200

Status
Completed
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

A.O.U. Federico II

Napoli, Italy, 80131

Status
Completed
 
Locations

A.O.U. Careggi

Firenze, Italy, 50141

Status
Completed
 
Locations

A.O.U. Policlinico Tor Vergata

Roma, Italy, 00133

Status
Completed
 
Locations

Clínica El Ángel

Málaga, Spain, 29007

Status
Completed
 
Locations

Hospital Sanitas La Zarzuela

Aravaca, Spain, 28023

Status
Completed
 
Locations

Hospital Universitario Clinica Puerta de Hierro

Majadahonda, Spain, 28222

Status
Completed
 
Locations

Hospital del Mar

Barcelona, Spain, 08003

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Leids Universitair Medisch Centrum

Leiden, Netherlands, 2333 ZA

Status
Completed
 
Locations

HagaZiekenhuis, locatie Leyenburg

DEN HAAG, Netherlands, 2545 CH

Status
Terminated
 
Locations

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

Status
Completed
 
Locations

Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 141 86

Status
Completed
 
Locations

Urohälsan Vättern

Jönköping, Sweden, 554 66

Status
Terminated
 
Locations

Tampereen yliopistollinen sairaala, keskussairaala

Tampere, Finland, FIN-33520

Status
Completed
 
Locations

Lääkärikeskus Mehiläinen Turku

Turku, Finland, 20100

Status
Completed
 
Locations

Terveystalo Oulu

Oulu, Finland, 90100

Status
Completed
 
Locations

Urologkliniken vid Carlanderska sjukhuset

Göteborg, Sweden, 405 45

Status
Completed
 
Locations

Dr. Wang Urologmottagning

Eskilstuna, Sweden, 633 40

Status
Completed
 
Locations

Universitetssjukhuset i Linköping

Linköping, Sweden, 581 85

Status
Completed
 
Locations

MediPlaza MVZ Koblenz GmbH

Koblenz, Germany, 56068

Status
Completed
 
Locations

Praxis Dr. S. Szymula

Leipzig, Germany, 04105

Status
Terminated
 
Locations

Praxis Hr. Dr. J. Willgerodt

Leipzig, Germany, 04109

Status
Terminated
 
Locations

Specialistmottagning i urologi, Tudorkliniken

Halmstad, Sweden, 302 45

Status
Completed
 

Trial Design