Trial Condition(s):
Erectile Dysfunction
Vardenafil ODT versus placebo in males with erectile dysfunction
Bayer Identifier:
12093
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Klinikum Osnabrück GmbH Osnabrück, Germany, 49076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. J. Willgerodt Leipzig, Germany, 04109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urologische Praxis Dr. D. Müller Bautzen, Germany, 02625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Hamburg Eppendorf (UKE) Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Prof. Dr. H. Porst Hamburg, Germany, 20354 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. D. Hennig Meißen, Germany, 01662 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken Nordoberpfalz AG - Klinikum Weiden Weiden, Germany, 92637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Morgiou - Marseille MARSEILLE, France, 13009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Gambetta - Lyon LYON, France, 69000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Medical Rue de Cannes LILLE, France, 59000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Edouard Herriot - Lyon Cedex LYON CEDEX, France, 69437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Martinon - Mont de Marsan MONT-DE-MARSAN, France, 40000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet medical Magellan PARIS, France, 75008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario de Canarias La Laguna, Spain, 38320 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital del Mar Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken Maria Hilf GmbH Mönchengladbach, Germany, 41063 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. Tim Schneider /B. Schneider Mülheim, Germany, 45468 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. W. Grohmann München, Germany, 81925 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Puget - Marseille MARSEILLE, France, 13006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CETPARP - Carolus - Lille LILLE, France, 59000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General Universitario de Alicante Alicante, Spain, 03010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CAP Sarrià Barcelona, Spain, 08034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU de Liège LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AZ St-Lucas Campus St-Lucas GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Saint-Jean/Kliniek Sint Jan BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Andros Mannenkliniek Arnhem ARNHEM, Netherlands, 6836 BH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations huisartsenpraktijk Systole LOSSER, Netherlands, 7581 BV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Entabeni Hospital Durban, South Africa, 4001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Florence Medical Centre Johannesburg, South Africa, 1818 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre for Diabetes & Endocrinology Johannesburg, South Africa, 2198 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Policlínico de Vigo - Clínica Povisa Vigo, Spain, 36211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Erasme/Erasmus Ziekenhuis BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Bongaerts - Dr Denier GENK, Belgium, 3600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZNA Middelheim ANTWERPEN, Belgium, 2020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Huisartsenmaatschap L.S.V. NIJVERDAL, Netherlands, 7442 LS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Huisartsenpraktijk Bierens en van Cleef Deurne, Netherlands, 5751 XJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Andros Mannenkliniek Leiden LEIDEN, Netherlands, 2316 ZL | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Andros Mannenkliniek Maastricht MAASTRICHT, Netherlands, 6212 XN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations I. Engelbrecht Reseach (Pty) Ltd Centurion, South Africa, 0140 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Randles Road Medical Centre Durban, South Africa, 4091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations DJW Navorsing Krugersdorp, South Africa, 1739 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Quatro Clinical Trials Institute Cape Town, South Africa, 7463 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mary Seeber Private Practice Pretoria, South Africa, 0083 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zuid Afrikaans Hospital Pretoria, South Africa, 0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Newkwa Medical Centre Durban, South Africa, 4037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Intercare Medical and Dental Centre Bellville Cape Town, South Africa, 7530 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Intercare Medical and Dental Centre Bellville Cape Town, South Africa, 7530 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Change From Baseline in International Index of Erectile Function (IIEF-EF Sub- Score) at 12 Weeks or LOCFTimeframe: from baseline up to 12 weeks
- Change in Percentage From Baseline in Success of Penetration at 12 WeeksTimeframe: from baseline up to 12 weeks of treatment
- Change From Baseline in Success of Erection Maintenance at 12 WeeksTimeframe: from baseline up to 12 weeks of treatment
Secondary Outcome
- Percentage of Subjects Achieving "Back to Normal" Erectile FunctionTimeframe: up to 12 weeks of treatment
- Change in Percentage From Baseline in Ability to Obtain an Erection at 12 WeeksTimeframe: from baseline up to 12 weeks of treatment
- Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 WeeksTimeframe: from baseline up to 12 weeks of treatment
- Change in Percentage From Baseline in Overall Satisfaction at 12 WeeksTimeframe: from baseline up to 12 weeks of treatment
- Change in Percentage From Baseline in Ability to Ejaculate at 12 WeeksTimeframe: from baseline up to 12 weeks of treatment
- Number of Sexual Attempts Till First Successful AttemptTimeframe: up to 12 weeks of treatment
- Change From Baseline in Ease With Erection at 12 Weeks or LOCFTimeframe: from baseline up to 12 weeks
- Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCFTimeframe: from baseline up to 12 weeks
- Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCFTimeframe: from baseline up to 12 weeks
- Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCFTimeframe: from baseline up to 12 weeks
- Change From Baseline in Confidence for Completion at 12 Weeks or LOCFTimeframe: from baseline up to 12 weeks
- Satisfaction With Medication at Week 12 or LOCFTimeframe: up to 12 weeks
- Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating ScaleTimeframe: up to 12 weeks of treatment
- Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in PlasmaTimeframe: Visit 5 after 12 weeks of treatment
- Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in PlasmaTimeframe: Visit 5 after 12 weeks of treatment
- Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in PlasmaTimeframe: Visit 5 after 12 weeks of treatment
- Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in PlasmaTimeframe: Visit 5 after 12 weeks of treatment
Additional Information
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