check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

12093

ClinicalTrials.gov Identifier:

NCT00631969

EudraCT Number:

2008-000536-40

EU CT Number:

Not Available
Vardenafil ODT versus placebo in males with erectile dysfunction

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 surgical prostatectomy for prostate cancer
    - Hereditary degenerative retinal disorders
    - History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision
    - Presence of penile anatomical abnormalities
    - Subjects who have been confirmed with phenylketonuria (PKU)
    - Spinal cord injury
    - Resting or postural hypotension or hypertension
    - Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin
    - Use of any treatment for ED within 7 days of Visit 1
    - History of congenital QT prolongation
    - History of syncope within the last 6 months prior to entry into the study

Trial summary

Enrollment Goal
362
Trial Dates
April 2008 - January 2009
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Vardenafil ODT (BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinikum Osnabrück GmbHOsnabrück, 49076, Germany
Completed
Praxis Hr. Dr. J. WillgerodtLeipzig, 04109, Germany
Completed
Urologische Praxis Dr. D. MüllerBautzen, 02625, Germany
Completed
Universitätsklinikum Hamburg Eppendorf (UKE)Hamburg, 20246, Germany
Completed
Praxis Hr. Prof. Dr. H. PorstHamburg, 20354, Germany
Completed
Praxis Hr. Dr. D. HennigMeißen, 01662, Germany
Terminated
Kliniken Nordoberpfalz AG - Klinikum WeidenWeiden, 92637, Germany
Completed
Cabinet Médical - Morgiou - MarseilleMARSEILLE, 13009, France
Completed
Cabinet Médical - Gambetta - LyonLYON, 69000, France
Completed
Cabinet Medical Rue de CannesLILLE, 59000, France
Completed
Hôpital Edouard Herriot - Lyon CedexLYON CEDEX, 69437, France
Completed
Cabinet Médical - Martinon - Mont de MarsanMONT-DE-MARSAN, 40000, France
Completed
Cabinet medical MagellanPARIS, 75008, France
Completed
Hospital Universitario de CanariasLa Laguna, 38320, Spain
Completed
Hospital del MarBarcelona, 08003, Spain
Completed
Kliniken Maria Hilf GmbHMönchengladbach, 41063, Germany
Completed
Praxis Drs. Tim Schneider /B. SchneiderMülheim, 45468, Germany
Completed
Praxis Hr. Dr. W. GrohmannMünchen, 81925, Germany
Completed
Cabinet Médical - Puget - MarseilleMARSEILLE, 13006, France
Completed
CETPARP - Carolus - LilleLILLE, 59000, France
Terminated
Hospital General Universitario de AlicanteAlicante, 03010, Spain
Terminated
CAP SarriàBarcelona, 08034, Spain
Completed
CHU de LiègeLIEGE, 4000, Belgium
Completed
AZ St-Lucas Campus St-LucasGENT, 9000, Belgium
Completed
Clinique Saint-Jean/Kliniek Sint JanBRUXELLES - BRUSSEL, 1000, Belgium
Completed
Andros Mannenkliniek ArnhemARNHEM, 6836 BH, Netherlands
Completed
huisartsenpraktijk SystoleLOSSER, 7581 BV, Netherlands
Completed
Entabeni HospitalDurban, 4001, South Africa
Completed
Florence Medical CentreJohannesburg, 1818, South Africa
Completed
Centre for Diabetes & EndocrinologyJohannesburg, 2198, South Africa
Completed
Hospital Policlínico de Vigo - Clínica PovisaVigo, 36211, Spain
Terminated
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Terminated
Hôpital Erasme/Erasmus ZiekenhuisBRUXELLES - BRUSSEL, 1070, Belgium
Terminated
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
Dr Bongaerts - Dr DenierGENK, 3600, Belgium
Terminated
ZNA MiddelheimANTWERPEN, 2020, Belgium
Completed
Huisartsenmaatschap L.S.V.NIJVERDAL, 7442 LS, Netherlands
Completed
Huisartsenpraktijk Bierens en van CleefDeurne, 5751 XJ, Netherlands
Completed
Andros Mannenkliniek LeidenLEIDEN, 2316 ZL, Netherlands
Terminated
Andros Mannenkliniek MaastrichtMAASTRICHT, 6212 XN, Netherlands
Completed
I. Engelbrecht Reseach (Pty) LtdCenturion, 0140, South Africa
Completed
Randles Road Medical CentreDurban, 4091, South Africa
Completed
DJW NavorsingKrugersdorp, 1739, South Africa
Completed
Quatro Clinical Trials InstituteCape Town, 7463, South Africa
Completed
Mary Seeber Private PracticePretoria, 0083, South Africa
Completed
Zuid Afrikaans HospitalPretoria, 0001, South Africa
Completed
Newkwa Medical CentreDurban, 4037, South Africa
Completed
Intercare Medical and Dental Centre BellvilleCape Town, 7530, South Africa
Terminated
Intercare Medical and Dental Centre BellvilleCape Town, 7530, South Africa

Primary Outcome

  • Change From Baseline in International Index of Erectile Function (IIEF-EF Sub- Score) at 12 Weeks or LOCF
    date_rangeTime Frame:
    from baseline up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change in Percentage From Baseline in Success of Penetration 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
  • Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma
    date_rangeTime Frame:
    Visit 5 after 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma
    date_rangeTime Frame:
    Visit 5 after 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma
    date_rangeTime Frame:
    Visit 5 after 12 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma
    date_rangeTime Frame:
    Visit 5 after 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 - POTENT I
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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