check_circleStudy Completed

Erectile dysfunction

Bayer Identifier:

14694

ClinicalTrials.gov Identifier:

NCT01168817

EudraCT Number:

2010-020122-18

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.

Key Participants Requirements

Sex

Male

Age

18 - 64 Years
  • - 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
  • - 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
August 2010 - May 2011
Phase
Phase 2
Could I Receive a placebo
Yes
Products
BAY98-7081
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Praxis Hr. Prof. Dr. H. PorstHamburg, 20354, Germany
Terminated
Universitätsklinikum Hamburg Eppendorf (UKE)Hamburg, 20246, Germany
Terminated
Klinikum Osnabrück GmbHOsnabrück, 49076, Germany
Completed
Praxis Drs. Tim Schneider /B. SchneiderMülheim, 45468, Germany
Completed
Praxis Hr. Dr. A. von KeitzMarburg, 35039, Germany
Completed
Kliniken Nordoberpfalz AG - Klinikum WeidenWeiden, 92637, Germany
Completed
Hopital Raymond Poincaré GarchesGARCHES, 92380, France
Completed
CETPARP - Carolus - LilleLILLE, 59000, France
Completed
Hôpital Edouard Herriot - Lyon CedexLYON CEDEX, 69437, France
Completed
Centre Hospitalier - Chambéry cedexCHAMBERY CEDEX, 73011, France
Completed
Hopital Carémeau - NîmesNIMES, 30000, France
Completed
Hôpital Pasteur - NiceNICE, 06200, France
Completed
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Completed
A.O.U. Federico IINapoli, 80131, Italy
Completed
A.O.U. CareggiFirenze, 50141, Italy
Completed
A.O.U. Policlinico Tor VergataRoma, 00133, Italy
Completed
Clínica El ÁngelMálaga, 29007, Spain
Completed
Hospital Sanitas La ZarzuelaAravaca, 28023, Spain
Completed
Hospital Universitario Clinica Puerta de HierroMajadahonda, 28222, Spain
Completed
Hospital del MarBarcelona, 08003, Spain
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Leids Universitair Medisch CentrumLeiden, 2333 ZA, Netherlands
Terminated
HagaZiekenhuis, locatie LeyenburgDEN HAAG, 2545 CH, Netherlands
Completed
Universitair Medisch Centrum GroningenGroningen, 9713 GZ, Netherlands
Completed
Karolinska Universitetssjukhuset i SolnaStockholm, 141 86, Sweden
Terminated
Urohälsan VätternJönköping, 554 66, Sweden
Completed
Tampereen yliopistollinen sairaala, keskussairaalaTampere, FIN-33520, Finland
Completed
Lääkärikeskus Mehiläinen TurkuTurku, 20100, Finland
Completed
Terveystalo OuluOulu, 90100, Finland
Completed
Urologkliniken vid Carlanderska sjukhusetGöteborg, 405 45, Sweden
Completed
Dr. Wang UrologmottagningEskilstuna, 633 40, Sweden
Completed
Universitetssjukhuset i LinköpingLinköping, 581 85, Sweden
Completed
MediPlaza MVZ Koblenz GmbHKoblenz, 56068, Germany
Terminated
Praxis Dr. S. SzymulaLeipzig, 04105, Germany
Terminated
Praxis Hr. Dr. J. WillgerodtLeipzig, 04109, Germany
Completed
Specialistmottagning i urologi, TudorklinikenHalmstad, 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 4
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Success rate assessed by subject diary question: 'Maintenance' (Did your erection last long enough to have sexual intercourse?)
    date_rangeTime Frame:
    Week 4
    enhanced_encryption
    Safety Issue:
    No
  • Success rate assessed by subject diary question: Penetration' (Were you able to insert your penis into your partner's vagina?)
    date_rangeTime Frame:
    Week 4
    enhanced_encryption
    Safety Issue:
    No

Trial design

A prospective, randomized, double-blind, double-dummy, placebo- and active controlled, multicenter study assessing the efficacy and safety of the combination BAY60-4552 / vardenafil compared to vardenafil (20 mg) for the treatment of erectile dysfunction not sufficiently responsive to standard therapy with PDE5 (Phosphodiesterase 5) inhibitors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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