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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
Collaborators:
Information provided by: Bayer
Identifier: NCT00867815

Purpose

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

Eligibility

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

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

Investigators

  • Investigator: Bayer Study Director - Study Director - Bayer

Locations

  • 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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