Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18-64 years
Phase:
PHASE2
Brief Summary
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 (Phospho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01168817
Start Date
August 1 2010
End Date
May 1 2011
Last Update
November 4 2014
Active Locations (36)
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1
Oulu, Finland, 90100
2
Tampere, Finland, FIN-33520
3
Turku, Finland, 20100
4
Chambéry, France, 73011