Clinical Trial: PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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 Ische
Brief Summary: 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.
Detailed Summary: Collected data will be compared to historic data of the same participant in case-crossover design.
Sponsor: Bayer
Current Primary Outcome: Confirmed diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION). [ Time Frame: Up to 67 days prior to study enrollment ]
Original Primary Outcome: Confirmed diagnosis of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [ Time Frame: Up to 7 weeks prior to study enrollment ]
Current Secondary Outcome: Any additional safety information provided by the subject. [ Time Frame: At baseline and after 12 weeks ]
Original Secondary Outcome: Any additional safety information provided by the subject [ Time Frame: At baseline and after 12 weeks ]
Information By: Bayer
Dates:
Date Received: March 23, 2009
Date Started: July 13, 2009
Date Completion: February 14, 2018
Last Updated: May 2, 2017
Last Verified: May 2017