Trial Condition(s):
Erectile Dysfunction
Vardenafil Orodispersible Tablet (ODT) versus placebo in males with erectile dysfunction, 50% of whom are to be 65 years or older.
Bayer Identifier:
12094
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
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 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations University Clinical Research, Inc. Pembroke Pines, United States, 33024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Florida Medical Research Aventura, United States, 33180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jacksonville Impotence Treatment Center Jacksonville, United States, 32223 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mount Sinai Medical Center New York, United States, 10029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Synergy Clinical Research Center National City, United States, 91950 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Roger Fincher, MD Spokane, United States, 99206 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Family Medical Associates Levittown, United States, 19056 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Arizona Research Center, Inc. Phoenix, United States, 85023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pearl Clinical Research Norristown, United States, 19401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tatum Highlands Medical Associates, PLLC Phoenix, United States, 85050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Columbus Urology Research, LLC Columbus, United States, 43220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Urology Group Cincinnati, United States, 45212-2787 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations East Valley Family Physicians, PLC Chandler, United States, 85224 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre de Recherche en Sante Sexuelle du Quebec Montreal, Canada, H2X 1N8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St.Joseph's Health Care-London London, Canada, N6A 4V2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Male Health Centres Oakville, Canada, L6H 3P1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique d'Urologie du Saguenay Chicoutimi, Canada, G7H 4A3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Rajiv Singal, MD Toronto, Canada, M4C 5T2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Consultorio Dr. Rodríguez Rivera Guadalajara, Mexico, 45040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asociación Mexicana para la Salud Sexual A. C. México D. F., Mexico, 14000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Berry Road Medical Centre St Leonards, Australia, 2065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabrini Medical Centre Melbourne, Australia, 3144 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Perth Human Sexuality Centre Perth, Australia, 6009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth II Medical Centre Nedlands, Australia, 6009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations San Diego Uro-Research San Diego, United States, 92103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations San Diego Clinical Trials San Diego, United States, 92120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mesa Family Medical Center Mesa, United States, 85203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fiel Family & Sports Medicine, PC Tempe, United States, 85283 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Bruce Gilbert, MD Great Neck, United States, 11021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tulane Medical Center New Orleans, United States, 70112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Irvine Center for Clinical Research Irvine, United States, 92618-3603 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Desert Clinical Research Mesa, United States, 85213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sunnybrook Health Sciences Centre Toronto, Canada, M4N 3M5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urology South Shore Research Greenfield Park, Canada, J4V 2H3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Santa Fé México, D. F., Mexico, 06700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Dalinde México, D. F., Mexico, 06700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Médico de las Américas Mérida, Mexico, 97001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sydney Men's Health Bondi Junction, Australia, 2022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Terrace Urology Adelaide, Australia, 5000 | 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
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 Last Observation Carried Forward (LOCF)Timeframe: from baseline up to 12 weeks
- Change in Percentage From Baseline in Success of Penetration (SEP2) 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
Additional Information
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