Trials / Terminated
TerminatedNCT00867815
PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Prospective Case Crossover Study to Assess Whether PDE5 Inhibitor Exposure in Men Increases the Risk for the Development of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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 description
Collected data will be compared to historic data of the same participant in case-crossover design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2009-07-13
- Primary completion
- 2017-12-29
- Completion
- 2018-03-28
- First posted
- 2009-03-24
- Last updated
- 2019-01-23
- Results posted
- 2019-01-23
Locations
13 sites across 3 countries: United States, Australia, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00867815. Inclusion in this directory is not an endorsement.