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:

NCT00655629

EudraCT Number:

Not Available

Study Completed

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
339
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Vardenafil ODT (BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

University Clinical Research, Inc.

Pembroke Pines, United States, 33024

Status
Completed
 
Locations

South Florida Medical Research

Aventura, United States, 33180

Status
Completed
 
Locations

Jacksonville Impotence Treatment Center

Jacksonville, United States, 32223

Status
Completed
 
Locations

Mount Sinai Medical Center

New York, United States, 10029

Status
Completed
 
Locations

Synergy Clinical Research Center

National City, United States, 91950

Status
Completed
 
Locations

Office of Dr. Roger Fincher, MD

Spokane, United States, 99206

Status
Completed
 
Locations

Family Medical Associates

Levittown, United States, 19056

Status
Completed
 
Locations

Arizona Research Center, Inc.

Phoenix, United States, 85023

Status
Completed
 
Locations

Pearl Clinical Research

Norristown, United States, 19401

Status
Completed
 
Locations

Tatum Highlands Medical Associates, PLLC

Phoenix, United States, 85050

Status
Completed
 
Locations

Columbus Urology Research, LLC

Columbus, United States, 43220

Status
Completed
 
Locations

The Urology Group

Cincinnati, United States, 45212-2787

Status
Completed
 
Locations

East Valley Family Physicians, PLC

Chandler, United States, 85224

Status
Completed
 
Locations

Centre de Recherche en Sante Sexuelle du Quebec

Montreal, Canada, H2X 1N8

Status
Terminated
 
Locations

St.Joseph's Health Care-London

London, Canada, N6A 4V2

Status
Completed
 
Locations

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada, H3T 1E2

Status
Terminated
 
Locations

The Male Health Centres

Oakville, Canada, L6H 3P1

Status
Completed
 
Locations

Clinique d'Urologie du Saguenay

Chicoutimi, Canada, G7H 4A3

Status
Completed
 
Locations

Office of Dr. Rajiv Singal, MD

Toronto, Canada, M4C 5T2

Status
Terminated
 
Locations

Consultorio Dr. Rodríguez Rivera

Guadalajara, Mexico, 45040

Status
Completed
 
Locations

Asociación Mexicana para la Salud Sexual A. C.

México D. F., Mexico, 14000

Status
Completed
 
Locations

Berry Road Medical Centre

St Leonards, Australia, 2065

Status
Completed
 
Locations

Cabrini Medical Centre

Melbourne, Australia, 3144

Status
Completed
 
Locations

Perth Human Sexuality Centre

Perth, Australia, 6009

Status
Completed
 
Locations

Queen Elizabeth II Medical Centre

Nedlands, Australia, 6009

Status
Completed
 
Locations

San Diego Uro-Research

San Diego, United States, 92103

Status
Completed
 
Locations

San Diego Clinical Trials

San Diego, United States, 92120

Status
Completed
 
Locations

Mesa Family Medical Center

Mesa, United States, 85203

Status
Completed
 
Locations

Fiel Family & Sports Medicine, PC

Tempe, United States, 85283

Status
Completed
 
Locations

Office of Dr. Bruce Gilbert, MD

Great Neck, United States, 11021

Status
Completed
 
Locations

Tulane Medical Center

New Orleans, United States, 70112

Status
Terminated
 
Locations

Irvine Center for Clinical Research

Irvine, United States, 92618-3603

Status
Completed
 
Locations

Desert Clinical Research

Mesa, United States, 85213

Status
Completed
 
Locations

Sunnybrook Health Sciences Centre

Toronto, Canada, M4N 3M5

Status
Terminated
 
Locations

Urology South Shore Research

Greenfield Park, Canada, J4V 2H3

Status
Completed
 
Locations

Hospital Santa Fé

México, D. F., Mexico, 06700

Status
Completed
 
Locations

Hospital Dalinde

México, D. F., Mexico, 06700

Status
Completed
 
Locations

Centro Médico de las Américas

Mérida, Mexico, 97001

Status
Completed
 
Locations

Sydney Men's Health

Bondi Junction, Australia, 2022

Status
Completed
 
Locations

South Terrace Urology

Adelaide, Australia, 5000

Status
Completed
 

Trial Design