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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Praxis Hr. Prof. Dr. H. Porst Hamburg, Germany, 20354 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Hamburg Eppendorf (UKE) Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Osnabrück GmbH Osnabrück, Germany, 49076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. Tim Schneider /B. Schneider Mülheim, Germany, 45468 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. A. von Keitz Marburg, Germany, 35039 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken Nordoberpfalz AG - Klinikum Weiden Weiden, Germany, 92637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Raymond Poincaré Garches GARCHES, France, 92380 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CETPARP - Carolus - Lille LILLE, France, 59000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Edouard Herriot - Lyon Cedex LYON CEDEX, France, 69437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier - Chambéry cedex CHAMBERY CEDEX, France, 73011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Carémeau - Nîmes NIMES, France, 30000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Pasteur - Nice NICE, France, 06200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Federico II Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Careggi Firenze, Italy, 50141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Tor Vergata Roma, Italy, 00133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica El Ángel Málaga, Spain, 29007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Sanitas La Zarzuela Aravaca, Spain, 28023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Clinica Puerta de Hierro Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital del Mar Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Leids Universitair Medisch Centrum Leiden, Netherlands, 2333 ZA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HagaZiekenhuis, locatie Leyenburg DEN HAAG, Netherlands, 2545 CH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitair Medisch Centrum Groningen Groningen, Netherlands, 9713 GZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska Universitetssjukhuset i Solna Stockholm, Sweden, 141 86 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urohälsan Vättern Jönköping, Sweden, 554 66 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tampereen yliopistollinen sairaala, keskussairaala Tampere, Finland, FIN-33520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lääkärikeskus Mehiläinen Turku Turku, Finland, 20100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Terveystalo Oulu Oulu, Finland, 90100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urologkliniken vid Carlanderska sjukhuset Göteborg, Sweden, 405 45 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Wang Urologmottagning Eskilstuna, Sweden, 633 40 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitetssjukhuset i Linköping Linköping, Sweden, 581 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MediPlaza MVZ Koblenz GmbH Koblenz, Germany, 56068 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. S. Szymula Leipzig, Germany, 04105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. J. Willgerodt Leipzig, Germany, 04109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Specialistmottagning i urologi, Tudorkliniken Halmstad, Sweden, 302 45 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Severity of erectile dysfunction assessed by the IIEF-EF (International Index of Erectile Function – Erectile Function subscale)Timeframe: Week 4
Secondary Outcome
- Success rate assessed by subject diary question: 'Maintenance' (Did your erection last long enough to have sexual intercourse?)Timeframe: Week 4
- Success rate assessed by subject diary question: Penetration' (Were you able to insert your penis into your partner's vagina?)Timeframe: Week 4
Additional Information
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