check_circleStudy Completed
Erectile Dysfunction
Bayer Identifier:
12093
ClinicalTrials.gov Identifier:
EudraCT Number:
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
MaleAge
18 YearsTrial summary
Enrollment Goal
362Trial Dates
April 2008 - January 2009Phase
Phase 3Could I Receive a placebo
YesProducts
Vardenafil ODT (BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Klinikum Osnabrück GmbH | Osnabrück, 49076, Germany |
Completed | Praxis Hr. Dr. J. Willgerodt | Leipzig, 04109, Germany |
Completed | Urologische Praxis Dr. D. Müller | Bautzen, 02625, Germany |
Completed | Universitätsklinikum Hamburg Eppendorf (UKE) | Hamburg, 20246, Germany |
Completed | Praxis Hr. Prof. Dr. H. Porst | Hamburg, 20354, Germany |
Completed | Praxis Hr. Dr. D. Hennig | Meißen, 01662, Germany |
Terminated | Kliniken Nordoberpfalz AG - Klinikum Weiden | Weiden, 92637, Germany |
Completed | Cabinet Médical - Morgiou - Marseille | MARSEILLE, 13009, France |
Completed | Cabinet Médical - Gambetta - Lyon | LYON, 69000, France |
Completed | Cabinet Medical Rue de Cannes | LILLE, 59000, France |
Completed | Hôpital Edouard Herriot - Lyon Cedex | LYON CEDEX, 69437, France |
Completed | Cabinet Médical - Martinon - Mont de Marsan | MONT-DE-MARSAN, 40000, France |
Completed | Cabinet medical Magellan | PARIS, 75008, France |
Completed | Hospital Universitario de Canarias | La Laguna, 38320, Spain |
Completed | Hospital del Mar | Barcelona, 08003, Spain |
Completed | Kliniken Maria Hilf GmbH | Mönchengladbach, 41063, Germany |
Completed | Praxis Drs. Tim Schneider /B. Schneider | Mülheim, 45468, Germany |
Completed | Praxis Hr. Dr. W. Grohmann | München, 81925, Germany |
Completed | Cabinet Médical - Puget - Marseille | MARSEILLE, 13006, France |
Completed | CETPARP - Carolus - Lille | LILLE, 59000, France |
Terminated | Hospital General Universitario de Alicante | Alicante, 03010, Spain |
Terminated | CAP Sarrià | Barcelona, 08034, Spain |
Completed | CHU de Liège | LIEGE, 4000, Belgium |
Completed | AZ St-Lucas Campus St-Lucas | GENT, 9000, Belgium |
Completed | Clinique Saint-Jean/Kliniek Sint Jan | BRUXELLES - BRUSSEL, 1000, Belgium |
Completed | Andros Mannenkliniek Arnhem | ARNHEM, 6836 BH, Netherlands |
Completed | huisartsenpraktijk Systole | LOSSER, 7581 BV, Netherlands |
Completed | Entabeni Hospital | Durban, 4001, South Africa |
Completed | Florence Medical Centre | Johannesburg, 1818, South Africa |
Completed | Centre for Diabetes & Endocrinology | Johannesburg, 2198, South Africa |
Completed | Hospital Policlínico de Vigo - Clínica Povisa | Vigo, 36211, Spain |
Terminated | Hospital Clínico Universitario de Valencia | Valencia, 46010, Spain |
Terminated | Hôpital Erasme/Erasmus Ziekenhuis | BRUXELLES - BRUSSEL, 1070, Belgium |
Terminated | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Completed | Dr Bongaerts - Dr Denier | GENK, 3600, Belgium |
Terminated | ZNA Middelheim | ANTWERPEN, 2020, Belgium |
Completed | Huisartsenmaatschap L.S.V. | NIJVERDAL, 7442 LS, Netherlands |
Completed | Huisartsenpraktijk Bierens en van Cleef | Deurne, 5751 XJ, Netherlands |
Completed | Andros Mannenkliniek Leiden | LEIDEN, 2316 ZL, Netherlands |
Terminated | Andros Mannenkliniek Maastricht | MAASTRICHT, 6212 XN, Netherlands |
Completed | I. Engelbrecht Reseach (Pty) Ltd | Centurion, 0140, South Africa |
Completed | Randles Road Medical Centre | Durban, 4091, South Africa |
Completed | DJW Navorsing | Krugersdorp, 1739, South Africa |
Completed | Quatro Clinical Trials Institute | Cape Town, 7463, South Africa |
Completed | Mary Seeber Private Practice | Pretoria, 0083, South Africa |
Completed | Zuid Afrikaans Hospital | Pretoria, 0001, South Africa |
Completed | Newkwa Medical Centre | Durban, 4037, South Africa |
Completed | Intercare Medical and Dental Centre Bellville | Cape Town, 7530, South Africa |
Terminated | Intercare Medical and Dental Centre Bellville | Cape Town, 7530, South Africa |
Primary Outcome
- Change From Baseline in International Index of Erectile Function (IIEF-EF Sub- Score) at 12 Weeks or LOCFdate_rangeTime Frame:from baseline up to 12 weeksenhanced_encryptionNoSafety Issue:
- Change in Percentage From Baseline in Success of Penetration at 12 Weeksdate_rangeTime Frame:from baseline up to 12 weeks of treatmentenhanced_encryptionNoSafety Issue:
- Change From Baseline in Success of Erection Maintenance at 12 Weeksdate_rangeTime Frame:from baseline up to 12 weeks of treatmentenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Percentage of Subjects Achieving "Back to Normal" Erectile Functiondate_rangeTime Frame:up to 12 weeks of treatmentenhanced_encryptionNoSafety Issue:
- Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeksdate_rangeTime Frame:from baseline up to 12 weeks of treatmentenhanced_encryptionNoSafety Issue:
- Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeksdate_rangeTime Frame:from baseline up to 12 weeks of treatmentenhanced_encryptionNoSafety Issue:
- Change in Percentage From Baseline in Overall Satisfaction at 12 Weeksdate_rangeTime Frame:from baseline up to 12 weeks of treatmentenhanced_encryptionNoSafety Issue:
- Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeksdate_rangeTime Frame:from baseline up to 12 weeks of treatmentenhanced_encryptionNoSafety Issue:
- Number of Sexual Attempts Till First Successful Attemptdate_rangeTime Frame:up to 12 weeks of treatmentenhanced_encryptionNoSafety Issue:
- Change From Baseline in Ease With Erection at 12 Weeks or LOCFdate_rangeTime Frame:from baseline up to 12 weeksenhanced_encryptionNoSafety Issue:
- Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCFdate_rangeTime Frame:from baseline up to 12 weeksenhanced_encryptionNoSafety Issue:
- Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCFdate_rangeTime Frame:from baseline up to 12 weeksenhanced_encryptionNoSafety Issue:
- Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCFdate_rangeTime Frame:from baseline up to 12 weeksenhanced_encryptionNoSafety Issue:
- Change From Baseline in Confidence for Completion at 12 Weeks or LOCFdate_rangeTime Frame:from baseline up to 12 weeksenhanced_encryptionNoSafety Issue:
- Satisfaction With Medication at Week 12 or LOCFdate_rangeTime Frame:up to 12 weeksenhanced_encryptionNoSafety Issue:
- Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scaledate_rangeTime Frame:up to 12 weeks of treatmentenhanced_encryptionNoSafety Issue:
- Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasmadate_rangeTime Frame:Visit 5 after 12 weeks of treatmentenhanced_encryptionNoSafety Issue:
- Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasmadate_rangeTime Frame:Visit 5 after 12 weeks of treatmentenhanced_encryptionNoSafety Issue:
- Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasmadate_rangeTime Frame:Visit 5 after 12 weeks of treatmentenhanced_encryptionNoSafety Issue:
- Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasmadate_rangeTime Frame:Visit 5 after 12 weeks of treatmentenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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