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Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men With Erectile Dysfunction Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

This study is currently Recruiting

November 2011 By Bayer

First Recieved on March 23, 2009

Last Updated on November 4, 2011

Sponsor: Bayer
Information provided by: Bayer
Identifier: NCT00867815


The primary objective of this study is to determine whether the use of PDE5 inhibitors (vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION

Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label


Ages Eligible for Study:40 Years
Genders Eligible for Study:Male
Accepts Healthy Volunteers:No

Inclusion Criteria: - Sudden visual loss in 1 eye within 45 days before entry to the study - History of erectile dysfunction at least 1 year prior to study enrollment - At least 1 dose of PDE5 inhibitor(s) taken within a year prior to the onset of loss of vision - Age 40 years or older Exclusion Criteria: - History of multiple sclerosis or optic neuritis - Evidence of temporal arteritis - History of vasculitis or collagen vascular disease - Previous history of NAION


  • Investigator: Bayer Study Director - Study Director - Bayer


  • Mesa, Arizona 85210 United States

  • Phoenix, Arizona 85032 United States

  • Fresno, California 93720 United States

  • Fullerton, California 92831 United States

  • Glendale, California 91205 United States

  • San Diego, California 92120 United States

  • St. Helena, California 94574 United States

  • Fairfield, Connecticut 06824 United States

  • Atlantis, Florida 33461 United States

  • Bradenton, Florida 34209 United States

  • Daytona Beach, Florida 32114 United States

  • Fort Myers, Florida 33912 United States

  • Fort Myers, Florida 33908 United States

  • Fort Myers, Florida 33901 United States

  • Gainesville, Florida 32605 United States

  • Jacksonville, Florida 32224 United States

  • Largo, Florida 33770 United States

  • Melbourne, Florida 32904 United States

  • Miami, Florida 33155 United States

  • Miami, Florida 33144 United States

  • Mount Dora, Florida 32757 United States

  • Orlando, Florida 32803 United States

  • Sarasota, Florida 34239 United States

  • Spring Hill, Florida 34609 United States

  • Tallahassee, Florida 32308 United States

  • Tamarac, Florida 33321 United States

  • Trinity, Florida 34655 United States

  • West Palm Beach, Florida 33409 United States

  • Winter Haven, Florida 33880 United States

  • Savannah, Georgia 31404 United States

  • Skokie, Illinois 60076 United States

  • Fort Wayne, Indiana 46804 United States

  • Indianapolis, Indiana 46290 United States

  • New Albany, Indiana 47150 United States

  • Louisville, Kentucky 40207 United States

  • Grand Rapids, Michigan 49503 United States

  • Warren, Michigan 48088 United States

  • Northfield, New Jersey 08225 United States

  • Brooklyn, New York 11219 United States

  • Great Neck, New York 11021 United States

  • New York, New York 10032 United States

  • Vestal, New York 13850 United States

  • Asheville, North Carolina 28803 United States

  • High Point, North Carolina 27262 United States

  • Shelby, North Carolina 28150 United States

  • Columbus, Ohio 43215-7312 United States

  • Philadelphia, Pennsylvania 19104 United States

  • Fort Worth, Texas 76104 United States

  • Houston, Texas 77030 United States

  • Houston, Texas 77025 United States

  • Sugar Land, Texas 77478 United States

  • Burlington, Vermont 05401 United States

  • Spokane, Washington 99204 United States

  • Edmonton, Alberta T5H 3V9 Canada

  • Ottawa, Ontario K1H 8L6 Canada

  • Toronto, Ontario M5G 1X5 Canada

  • Montreal, Quebec H3G 1A4 Canada

Conditions related to this trial:

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