check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

12094

ClinicalTrials.gov Identifier:

NCT00655629

EudraCT Number:

Not Available

EU CT Number:

Not Available
Vardenafil Orodispersible Tablet (ODT) versus placebo in males with erectile dysfunction, 50% of whom are to be 65 years or older.

Trial purpose

This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

Key Participants Requirements

Sex

Male

Age

18 Years
  • - Males 18 years-of-age or older.
    - Stable, heterosexual relationship for at least 6 months.
    - A history of erectile dysfunction (ED) for at least 6 months
  • - Any underlying cardiovascular condition, including unstable angina pectoris
    - History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
    - Uncontrolled atrial fibrillation / flutter at screening
    - History of congenital QT prolongation
    - History of surgical prostatectomy due to prostate cancer
    - Hereditary degenerative retinal disorders
    - History of loss of vision because of NAION (Non-arteritic anterior ischemic optic neuropathy), temporary or permanent loss of vision
    - Presence of penile anatomical abnormalities
    - Spinal cord injury
    - Resting or postural hypotension or hypertension
    - Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha-blockers, HIV (Human immunodeficiency virus) protease inhibitors, itraconazole or ketoconazole, and clarithromycin and erythromycin.
    - Subjects taking medication known to prolong QT interval, such as Type Ia and Type 3 anti-arrhythmics.
    - Subjects who have been confirmed with phenylketonuria (PKU).
    - Use of any treatment for ED within 7 days of Visit 1.

Trial summary

Enrollment Goal
339
Trial Dates
April 2008 - February 2009
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Vardenafil ODT (BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
University Clinical Research, Inc.Pembroke Pines, 33024, United States
Completed
South Florida Medical ResearchAventura, 33180, United States
Completed
Jacksonville Impotence Treatment CenterJacksonville, 32223, United States
Completed
Mount Sinai Medical CenterNew York, 10029, United States
Completed
Synergy Clinical Research CenterNational City, 91950, United States
Completed
Office of Dr. Roger Fincher, MDSpokane, 99206, United States
Completed
Family Medical AssociatesLevittown, 19056, United States
Completed
Arizona Research Center, Inc.Phoenix, 85023, United States
Completed
Pearl Clinical ResearchNorristown, 19401, United States
Completed
Tatum Highlands Medical Associates, PLLCPhoenix, 85050, United States
Completed
Columbus Urology Research, LLCColumbus, 43220, United States
Completed
The Urology GroupCincinnati, 45212-2787, United States
Completed
East Valley Family Physicians, PLCChandler, 85224, United States
Terminated
Centre de Recherche en Sante Sexuelle du QuebecMontreal, H2X 1N8, Canada
Completed
St.Joseph's Health Care-LondonLondon, N6A 4V2, Canada
Terminated
Sir Mortimer B. Davis Jewish General HospitalMontreal, H3T 1E2, Canada
Completed
The Male Health CentresOakville, L6H 3P1, Canada
Completed
Clinique d'Urologie du SaguenayChicoutimi, G7H 4A3, Canada
Terminated
Office of Dr. Rajiv Singal, MDToronto, M4C 5T2, Canada
Completed
Consultorio Dr. Rodríguez RiveraGuadalajara, 45040, Mexico
Completed
Asociación Mexicana para la Salud Sexual A. C.México D. F., 14000, Mexico
Completed
Berry Road Medical CentreSt Leonards, 2065, Australia
Completed
Cabrini Medical CentreMelbourne, 3144, Australia
Completed
Perth Human Sexuality CentrePerth, 6009, Australia
Completed
Queen Elizabeth II Medical CentreNedlands, 6009, Australia
Completed
San Diego Uro-ResearchSan Diego, 92103, United States
Completed
San Diego Clinical TrialsSan Diego, 92120, United States
Completed
Mesa Family Medical CenterMesa, 85203, United States
Completed
Fiel Family & Sports Medicine, PCTempe, 85283, United States
Completed
Office of Dr. Bruce Gilbert, MDGreat Neck, 11021, United States
Terminated
Tulane Medical CenterNew Orleans, 70112, United States
Completed
Irvine Center for Clinical ResearchIrvine, 92618-3603, United States
Completed
Desert Clinical ResearchMesa, 85213, United States
Terminated
Sunnybrook Health Sciences CentreToronto, M4N 3M5, Canada
Completed
Urology South Shore ResearchGreenfield Park, J4V 2H3, Canada
Completed
Hospital Santa FéMéxico, D. F., 06700, Mexico
Completed
Hospital DalindeMéxico, D. F., 06700, Mexico
Completed
Centro Médico de las AméricasMérida, 97001, Mexico
Completed
Sydney Men's HealthBondi Junction, 2022, Australia
Completed
South Terrace UrologyAdelaide, 5000, Australia

Primary Outcome

  • Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)
    date_rangeTime Frame:
    from baseline up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks
    date_rangeTime Frame:
    from baseline up to 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Success of Erection Maintenance at 12 Weeks
    date_rangeTime Frame:
    from baseline up to 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Percentage of Subjects Achieving "Back to Normal" Erectile Function
    date_rangeTime Frame:
    up to 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
    date_rangeTime Frame:
    from baseline up to 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
    date_rangeTime Frame:
    from baseline up to 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
    date_rangeTime Frame:
    from baseline up to 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
    date_rangeTime Frame:
    from baseline up to 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Number of Sexual Attempts Till First Successful Attempt
    date_rangeTime Frame:
    up to 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Ease With Erection at 12 Weeks or LOCF
    date_rangeTime Frame:
    from baseline up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
    date_rangeTime Frame:
    from baseline up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
    date_rangeTime Frame:
    from baseline up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
    date_rangeTime Frame:
    from baseline up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
    date_rangeTime Frame:
    from baseline up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Satisfaction With Medication at Week 12 or LOCF
    date_rangeTime Frame:
    up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
    date_rangeTime Frame:
    up to 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No

Trial design

Pivotal phase III trial to investigate the efficacy and safety of an Orodispersible Tablet vardenafil versus placebo in the treatment of men with Erectile dysfunction (ED) - a fixed-dose, double-blind, randomized multi-center Trial
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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