Safety Study Looking at the Effects of Stendra on Vision

Completed · Phase 4 · Has a placebo group

Conditions studied: Vision

In brief

The purpose of this study is to see if Stendra causes any changes in vision, eye pressure, pupil dilation, and color vision in healthy males.

Key facts

Study ID

NCT02033200

Run by

VIVUS LLC

People needed

80

Starts

2014-01-01

Expected to finish

2014-01-01

Last updated by the study team

2015-03-13

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult males 18 to 45 years of age, inclusive
• Non-tobacco user for at least 6 months prior to first dose

You may not qualify if…

• History or presence of retinal disease or any vision defects including color vision
• Intraocular pressure value ≥ 22mm Hg
• Resting heart rate < 45 or > 90 beats per minute (3 rechecks)
• Systolic blood pressure < 90 or > 140 mm Hg or Diastolic blood pressure < 50 or >90 mm Hg (3 rechecks)
• Initiation or change in dose of any α-blockers 14 days prior to randomization

Where it is running

• Celerion Inc — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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