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Healthy Volunteer Study of Sildenafil Effects Upon Vision

Primary Purpose

Blindness

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sildenafil
Sponsored by
University of Cambridge
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Blindness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: male - Exclusion Criteria: -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 9, 2005
    Last Updated
    November 9, 2005
    Sponsor
    University of Cambridge
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00251784
    Brief Title
    Healthy Volunteer Study of Sildenafil Effects Upon Vision
    Official Title
    A Double-Blind, Randomised, Placebo Controlled Healthy Volunteer Study to Investigate the Nature and Origin of the Disturbance of Vision Induced by Single Oral Doses of Sildenafil
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2003
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2003 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Cambridge

    4. Oversight

    5. Study Description

    Brief Summary
    Patients sometimes report subjective visual effects when taking sildenafil. Our study set out to measure these in a controlled setting. Subjects were asked to detect patterns presented on a monitor screen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blindness

    7. Study Design

    Primary Purpose
    Educational/Counseling/Training
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Sildenafil

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: male - Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Morris J Brown, MD
    Organizational Affiliation
    University of Cambridge
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    John Mollon, FRS
    Organizational Affiliation
    University of Cambridge
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Healthy Volunteer Study of Sildenafil Effects Upon Vision

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