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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01168817
First received: July 22, 2010
Last updated: November 3, 2014
Last verified: November 2014
  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.


Condition Intervention Phase
Erectile Dysfunction
Drug: BAY60-4552 plus Vardenafil
Drug: Vardenafil
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Severity of erectile dysfunction assessed by the IIEF-EF (International Index of Erectile Function - Erectile Function subscale) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Success rate assessed by subject diary question: 'Maintenance' (Did your erection last long enough to have sexual intercourse?) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Success rate assessed by subject diary question: Penetration' (Were you able to insert your penis into your partner's vagina?) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: August 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY60-4552 plus Vardenafil
Treatment with 3 tablets once daily for 4 weeks (Vardenafil 10 mg plus BAY60-4552 1.0 mg)
Active Comparator: Arm 2 Drug: Vardenafil
Treatment with 3 tablets once daily for 4 weeks (Vardenafil 20 mg)
Placebo Comparator: Arm 3 Drug: Placebo
Treatment with 3 tablets once daily for 4 weeks (Placebo)

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168817

Locations
Finland
Oulu, Finland, 90100
Tampere, Finland, FIN-33520
Turku, Finland, 20100
France
Chambery Cedex, France, 73011
Garches, France, 92380
Lille, France, 59000
Lyon Cedex, France, 69437
Nice, France, 06200
Nimes, France, 30000
Germany
Weiden, Bayern, Germany, 92637
Marburg, Hessen, Germany, 35039
Osnabrück, Niedersachsen, Germany, 49076
Mülheim, Nordrhein-Westfalen, Germany, 45468
Koblenz, Rheinland-Pfalz, Germany, 56068
Leipzig, Sachsen, Germany, 04105
Leipzig, Sachsen, Germany, 04109
Hamburg, Germany, 20354
Hamburg, Germany, 20246
Italy
Firenze, Italy, 50141
Milano, Italy, 20132
Napoli, Italy, 80131
Roma, Italy, 00133
Netherlands
Den Haag, Netherlands, 2545 CH
Groningen, Netherlands, 9713 GZ
Leiden, Netherlands, 2333 ZA
Spain
Aravaca, Madrid, Spain, 28023
Majadahonda, Madrid, Spain, 28222
Barcelona, Spain, 08003
Barcelona, Spain, 08036
Málaga, Spain, 29007
Sweden
Eskilstuna, Sweden, 633 40
Göteborg, Sweden, 405 45
Halmstad, Sweden, 302 45
Jönköping, Sweden, 554 66
Linköping, Sweden, 581 85
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01168817     History of Changes
Other Study ID Numbers: 14694, 2010-020122-18
Study First Received: July 22, 2010
Last Updated: November 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Spain: Spanish Agency of Medicines

Keywords provided by Bayer:
Combination Drug Therapy
Phosphodiesterase inhibitors

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Vardenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014