Trial Condition(s):
Erectile Dysfunction
Vardenafil ODT versus placebo in males with erectile dysfunction
Bayer Identifier:
12093
ClinicalTrials.gov Identifier:
Not Available
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 Investigative Site Osnabrück, Germany, 49076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bautzen, Germany, 02625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20354 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Meißen, Germany, 01662 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Weiden, Germany, 92637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE, France, 13009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LYON, France, 69000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE, France, 59000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LYON CEDEX, France, 69437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONT-DE-MARSAN, France, 40000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site La Laguna, Spain, 38320 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mönchengladbach, Germany, 41063 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mülheim, Germany, 45468 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81925 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE, France, 13006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Alicante, Spain, 03010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ARNHEM, Netherlands, 6836 BH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LOSSER, Netherlands, 7581 BV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durban, South Africa, 4001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 1818 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2198 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vigo, Spain, 36211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GENK, Belgium, 3600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ANTWERPEN, Belgium, 2020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIJVERDAL, Netherlands, 7442 LS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Deurne, Netherlands, 5751 XJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEIDEN, Netherlands, 2316 ZL | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MAASTRICHT, Netherlands, 6212 XN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Centurion, South Africa, 0140 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durban, South Africa, 4091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krugersdorp, South Africa, 1739 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cape Town, South Africa, 7463 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0083 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durban, South Africa, 4037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cape Town, South Africa, 7530 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site 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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