Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Bayer |
---|---|
Information provided by: | Bayer |
ClinicalTrials.gov 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
Condition | Intervention | Phase |
---|---|---|
Anterior Ischemic Optic Neuropathy |
Drug: Diagnostic procedures |
Phase IV |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Crossover Assignment, Safety Study |
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 Ischemic Optic Neuropathy (NAION) |
Estimated Enrollment: | 284 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1 |
Drug: Diagnostic procedures
The patients will not receive any study drug in this study. The patients will have ophthalmological (eye) examinations, blood work and will complete an interview
|
Collected data will be compared to historic data of the same participant in case-crossover design
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
United States, California | |
St. Helena, California, United States, 94574 | |
United States, Connecticut | |
Fairfield, Connecticut, United States, 06824 | |
United States, Florida | |
Fort Myers, Florida, United States, 33908 | |
Largo, Florida, United States, 33770 | |
Sarasota, Florida, United States, 34239 | |
Tallahassee, Florida, United States, 32308 | |
Miami, Florida, United States, 33155 | |
United States, Georgia | |
Savannah, Georgia, United States, 31404 | |
United States, Illinois | |
Skokie, Illinois, United States, 60076 | |
United States, Indiana | |
Indianapolis, Indiana, United States, 46290 | |
United States, Michigan | |
Grand Rapids, Michigan, United States, 49503 | |
Warren, Michigan, United States, 48088 | |
United States, New Jersey | |
Northfield, New Jersey, United States, 08225 | |
United States, New York | |
Vestal, New York, United States, 13850 | |
Brooklyn, New York, United States, 11219 | |
United States, Texas | |
Houston, Texas, United States, 77030 | |
Houston, Texas, United States, 77025 | |
United States, Washington | |
Spokane, Washington, United States, 99204 | |
Canada, Ontario | |
Toronto, Ontario, Canada, M5G 1X5 | |
Canada, Quebec | |
Montreal, Quebec, Canada, H2W 1S6 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Healthcare Pharmaceuticals Inc. ( Medical Affairs Therapeutic Area Head ) |
Study ID Numbers: | 12912 |
Study First Received: | March 23, 2009 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00867815 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non-arteritic Anterior Ischemic Optic Neuropathy NAION PDE5 inhibitors vardenafil Levitra sildenafil Viagra |
Tadalafil Cialis acute vision loss vision loss blurred vision optic neuropathy erectile dysfunction |
Sexual Dysfunctions, Psychological Eye Diseases Vascular Diseases Optic Neuropathy, Anterior Ischemic Sildenafil Blindness Ischemia Genital Diseases, Male |
Optic Neuropathy, Ischemic Vardenafil Sexual Dysfunction, Physiological Mental Disorders Optic Nerve Disorder Tadalafil Optic Nerve Diseases Erectile Dysfunction |
Sexual Dysfunctions, Psychological Eye Diseases Nervous System Diseases Vascular Diseases Ischemia Genital Diseases, Male Sexual and Gender Disorders Optic Neuropathy, Ischemic |
Pathologic Processes Sexual Dysfunction, Physiological Mental Disorders Optic Nerve Diseases Cardiovascular Diseases Cranial Nerve Diseases Erectile Dysfunction |