- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01168817
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
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Oulu, Finland, 90100
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Tampere, Finland, FIN-33520
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Turku, Finland, 20100
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Chambery Cedex, France, 73011
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Garches, France, 92380
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Lille, France, 59000
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Lyon Cedex, France, 69437
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Nice, France, 06200
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Nimes, France, 30000
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Hamburg, Germany, 20246
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Hamburg, Germany, 20354
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Bayern
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Weiden, Bayern, Germany, 92637
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Hessen
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Marburg, Hessen, Germany, 35039
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Niedersachsen
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Osnabrück, Niedersachsen, Germany, 49076
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Nordrhein-Westfalen
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Mülheim, Nordrhein-Westfalen, Germany, 45468
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Rheinland-Pfalz
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Koblenz, Rheinland-Pfalz, Germany, 56068
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Sachsen
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Leipzig, Sachsen, Germany, 04109
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Leipzig, Sachsen, Germany, 04105
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Firenze, Italy, 50141
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Milano, Italy, 20132
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Napoli, Italy, 80131
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Roma, Italy, 00133
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Den Haag, Netherlands, 2545 CH
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Groningen, Netherlands, 9713 GZ
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Leiden, Netherlands, 2333 ZA
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Barcelona, Spain, 08036
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Barcelona, Spain, 08003
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Málaga, Spain, 29007
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Madrid
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Aravaca, Madrid, Spain, 28023
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Majadahonda, Madrid, Spain, 28222
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Eskilstuna, Sweden, 633 40
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Göteborg, Sweden, 405 45
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Halmstad, Sweden, 302 45
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Jönköping, Sweden, 554 66
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Linköping, Sweden, 581 85
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Stockholm, Sweden, 141 86
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Arm 2
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Treatment with 3 tablets once daily for 4 weeks (Vardenafil 20 mg)
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Experimental: Arm 1
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Treatment with 3 tablets once daily for 4 weeks (Vardenafil 10 mg plus BAY60-4552 1.0 mg)
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Placebo Comparator: Arm 3
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Treatment with 3 tablets once daily for 4 weeks (Placebo)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Severity of erectile dysfunction assessed by the IIEF-EF (International Index of Erectile Function - Erectile Function subscale)
Time Frame: Week 4
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Week 4
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Success rate assessed by subject diary question: 'Maintenance' (Did your erection last long enough to have sexual intercourse?)
Time Frame: Week 4
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Week 4
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Success rate assessed by subject diary question: Penetration' (Were you able to insert your penis into your partner's vagina?)
Time Frame: Week 4
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Week 4
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14694
- 2010-020122-18 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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