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

NCT01168817 | Completed Phase 2

• 2 other identifiers: 146942010-020122-18
• Study Type: interventional
• Target: 140
• Locations: 7 countries
• Sites: 36

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 (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.

Conditions

Erectile Dysfunction

Keywords

Combination Drug Therapy; Phosphodiesterase inhibitors

Outcome Measures

Primary Outcomes (1)

• Severity of erectile dysfunction assessed by the IIEF-EF (International Index of Erectile Function - Erectile Function subscale)

  Week 4

Secondary Outcomes (2)

• Success rate assessed by subject diary question: 'Maintenance' (Did your erection last long enough to have sexual intercourse?)

  Week 4

• Success rate assessed by subject diary question: Penetration' (Were you able to insert your penis into your partner's vagina?)

  Week 4

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: BAY60-4552 plus Vardenafil

Arm 2

ACTIVE COMPARATOR

Drug: Vardenafil

Arm 3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BAY60-4552 plus Vardenafil DRUG

Treatment with 3 tablets once daily for 4 weeks (Vardenafil 10 mg plus BAY60-4552 1.0 mg)

Arm 1

Vardenafil DRUG

Treatment with 3 tablets once daily for 4 weeks (Vardenafil 20 mg)

Arm 2

Placebo DRUG

Treatment with 3 tablets once daily for 4 weeks (Placebo)

Arm 3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (36)

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Oulu, 90100, Finland

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Tampere, FIN-33520, Finland

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Turku, 20100, Finland

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Chambéry, 73011, France

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Garches, 92380, France

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Lille, 59000, France

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Lyon, 69437, France

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Nice, 06200, France

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Nîmes, 30000, France

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Weiden, Bavaria, 92637, Germany

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Hamburg, Hamburg, 20246, Germany

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Hamburg, Hamburg, 20354, Germany

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Marburg, Hesse, 35039, Germany

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Osnabrück, Lower Saxony, 49076, Germany

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Mülheim, North Rhine-Westphalia, 45468, Germany

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Koblenz, Rhineland-Palatinate, 56068, Germany

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Leipzig, Saxony, 04105, Germany

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Leipzig, Saxony, 04109, Germany

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Florence, 50141, Italy

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Milan, 20132, Italy

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Napoli, 80131, Italy

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Roma, 00133, Italy

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Groningen, Provincie Groningen, 9713 GZ, Netherlands

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Leiden, 2333 ZA, Netherlands

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The Hague, 2545 CH, Netherlands

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Barcelona, Barcelona, 08003, Spain

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Barcelona, Barcelona, 08036, Spain

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Aravaca, Madrid, 28023, Spain

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Majadahonda, Madrid, 28222, Spain

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Málaga, Málaga, 29007, Spain

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Eskilstuna, 633 40, Sweden

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Gothenburg, 405 45, Sweden

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Halmstad, 302 45, Sweden

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Jönköping, 554 66, Sweden

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Linköping, 581 85, Sweden

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Stockholm, 141 86, Sweden

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MeSH Terms

Conditions

Erectile Dysfunction

Interventions

BAY 60-4552; Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 23, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 4, 2014

Record last verified: 2014-11

Locations

SE (6); FR (6); NL (3); IT (4); FI (3); DE (9); ES (5)