check_circleStudy Completed
Erectile dysfunction
Bayer Identifier:
14694
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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.
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.
Key Participants Requirements
Sex
MaleAge
18 - 64 YearsTrial summary
Enrollment Goal
140Trial Dates
August 2010 - May 2011Phase
Phase 2Could I Receive a placebo
YesProducts
BAY98-7081Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Praxis Hr. Prof. Dr. H. Porst | Hamburg, 20354, Germany |
Terminated | Universitätsklinikum Hamburg Eppendorf (UKE) | Hamburg, 20246, Germany |
Terminated | Klinikum Osnabrück GmbH | Osnabrück, 49076, Germany |
Completed | Praxis Drs. Tim Schneider /B. Schneider | Mülheim, 45468, Germany |
Completed | Praxis Hr. Dr. A. von Keitz | Marburg, 35039, Germany |
Completed | Kliniken Nordoberpfalz AG - Klinikum Weiden | Weiden, 92637, Germany |
Completed | Hopital Raymond Poincaré Garches | GARCHES, 92380, France |
Completed | CETPARP - Carolus - Lille | LILLE, 59000, France |
Completed | Hôpital Edouard Herriot - Lyon Cedex | LYON CEDEX, 69437, France |
Completed | Centre Hospitalier - Chambéry cedex | CHAMBERY CEDEX, 73011, France |
Completed | Hopital Carémeau - Nîmes | NIMES, 30000, France |
Completed | Hôpital Pasteur - Nice | NICE, 06200, France |
Completed | IRCCS Fondazione San Raffaele | Milano, 20132, Italy |
Completed | A.O.U. Federico II | Napoli, 80131, Italy |
Completed | A.O.U. Careggi | Firenze, 50141, Italy |
Completed | A.O.U. Policlinico Tor Vergata | Roma, 00133, Italy |
Completed | Clínica El Ángel | Málaga, 29007, Spain |
Completed | Hospital Sanitas La Zarzuela | Aravaca, 28023, Spain |
Completed | Hospital Universitario Clinica Puerta de Hierro | Majadahonda, 28222, Spain |
Completed | Hospital del Mar | Barcelona, 08003, Spain |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Completed | Leids Universitair Medisch Centrum | Leiden, 2333 ZA, Netherlands |
Terminated | HagaZiekenhuis, locatie Leyenburg | DEN HAAG, 2545 CH, Netherlands |
Completed | Universitair Medisch Centrum Groningen | Groningen, 9713 GZ, Netherlands |
Completed | Karolinska Universitetssjukhuset i Solna | Stockholm, 141 86, Sweden |
Terminated | Urohälsan Vättern | Jönköping, 554 66, Sweden |
Completed | Tampereen yliopistollinen sairaala, keskussairaala | Tampere, FIN-33520, Finland |
Completed | Lääkärikeskus Mehiläinen Turku | Turku, 20100, Finland |
Completed | Terveystalo Oulu | Oulu, 90100, Finland |
Completed | Urologkliniken vid Carlanderska sjukhuset | Göteborg, 405 45, Sweden |
Completed | Dr. Wang Urologmottagning | Eskilstuna, 633 40, Sweden |
Completed | Universitetssjukhuset i Linköping | Linköping, 581 85, Sweden |
Completed | MediPlaza MVZ Koblenz GmbH | Koblenz, 56068, Germany |
Terminated | Praxis Dr. S. Szymula | Leipzig, 04105, Germany |
Terminated | Praxis Hr. Dr. J. Willgerodt | Leipzig, 04109, Germany |
Completed | Specialistmottagning i urologi, Tudorkliniken | Halmstad, 302 45, Sweden |
Primary Outcome
- Severity of erectile dysfunction assessed by the IIEF-EF (International Index of Erectile Function – Erectile Function subscale)date_rangeTime Frame:Week 4enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Success rate assessed by subject diary question: 'Maintenance' (Did your erection last long enough to have sexual intercourse?)date_rangeTime Frame:Week 4enhanced_encryptionNoSafety Issue:
- Success rate assessed by subject diary question: Penetration' (Were you able to insert your penis into your partner's vagina?)date_rangeTime Frame:Week 4enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
3Additional Information
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