Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.

Completed · Phase 3 · Has a placebo group

Conditions studied: Erectile Dysfunction

In brief

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 facts

Study ID

NCT00655629

Run by

Bayer

People needed

339

Starts

2008-04-01

Expected to finish

2009-02-01

Last updated by the study team

2014-08-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• East Valley Family Physicians, PLC — Chandler, Arizona, United States
• Mesa Family Medical Center — Mesa, Arizona, United States
• Desert Clinical Research — Mesa, Arizona, United States
• Arizona Research Center, Inc. — Phoenix, Arizona, United States
• Tatum Highlands Medical Associates, PLLC — Phoenix, Arizona, United States
• Fiel Family & Sports Medicine, PC — Tempe, Arizona, United States
• Irvine Center for Clinical Research — Irvine, California, United States
• Synergy Clinical Research Center — National City, California, United States
• San Diego Uro-Research — San Diego, California, United States
• San Diego Clinical Trials — San Diego, California, United States
• South Florida Medical Research — Aventura, Florida, United States
• Jacksonville Impotence Treatment Center — Jacksonville, Florida, United States
• University Clinical Research, Inc. — Pembroke Pines, Florida, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• Office of Dr. Bruce Gilbert, MD — Great Neck, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• The Urology Group — Cincinnati, Ohio, United States
• Columbus Urology Research, LLC — Columbus, Ohio, United States
• Family Medical Associates — Levittown, Pennsylvania, United States
• Pearl Clinical Research — Norristown, Pennsylvania, United States
• Office of Dr. Roger Fincher, MD — Spokane, Washington, United States
• Sydney Men's Health — Bondi Junction, New South Wales, Australia
• Berry Road Medical Centre — St Leonards, New South Wales, Australia
• South Terrace Urology — Adelaide, South Australia, Australia
• Cabrini Medical Centre — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.