Safety Study Looking at the Effects of Stendra on Vision

NCT ID: NCT02033200

Last Updated: 2015-03-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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The objectives of this study are to assess the effect of Stendra on visual acuity, intraocular pressure, pupillometry, and color vision discrimination in healthy male subjects.

Conditions

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Vision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active

Stendra 200 mg

Group Type EXPERIMENTAL

Stendra 200 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Placebo

placebo

Group Type PLACEBO_COMPARATOR

Stendra 200 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Stendra 200 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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avanafil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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VIVUS LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Celerion Inc

Tempe, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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TA-402

Identifier Type: -

Identifier Source: org_study_id

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