Safety Study Looking at the Effects of Stendra on Vision

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VIVUS, Inc.

Criteria

Inclusion Criteria:

• Healthy adult males 18 to 45 years of age, inclusive

• Non-tobacco user for at least 6 months prior to first dose

Exclusion Criteria:

• 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