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Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)

Primary Purpose

Impotence

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Viagra
Placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impotence

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: clinical diagnosis of erectile dysfunction (ED) lower urinary tract symptoms (LUTS) Exclusion Criteria: previous prostate surgery or invasive intervention for BPH active urinary tract disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo

    Secondary Outcome Measures

    Effect on: IPSS Effect on IPSS QoL Orgasmic Function
    Sexual Desire Intercourse Satisfaction and Overall Satisfaction domains of IIEF Qmax by uroflometry
    Event Log Variables

    Full Information

    First Posted
    August 31, 2005
    Last Updated
    January 28, 2021
    Sponsor
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00143221
    Brief Title
    Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)
    Official Title
    A Multicenter, Randomized, Parallel Group, Double-blind, Placebo-controlled Flexible Dose Study With and Open-label Extension to Assess the Efficacy and Safety of Viagra (Sildenafil Citrate) in the Treatment of Men With Erectile Dysfunction (ED) and Concomitant Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) in the United States
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2005 (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether Viagra is effective in treating erectile dysfunction and lower urinary tract symptoms in men affected by both conditions.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    350 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Viagra
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Comparison of change in EF domain of IIEF at Week 12 between Viagra and placebo
    Secondary Outcome Measure Information:
    Title
    Effect on: IPSS Effect on IPSS QoL Orgasmic Function
    Title
    Sexual Desire Intercourse Satisfaction and Overall Satisfaction domains of IIEF Qmax by uroflometry
    Title
    Event Log Variables

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: clinical diagnosis of erectile dysfunction (ED) lower urinary tract symptoms (LUTS) Exclusion Criteria: previous prostate surgery or invasive intervention for BPH active urinary tract disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18597830
    Citation
    McVary KT, Siegel RL, Carlsson M. Sildenafil citrate improves erectile function and lower urinary tract symptoms independent of baseline body mass index or LUTS severity. Urology. 2008 Sep;72(3):575-9. doi: 10.1016/j.urology.2008.04.020. Epub 2008 Jul 2.
    Results Reference
    derived
    PubMed Identifier
    17887993
    Citation
    McVary KT, Kaufman J, Young JM, Tseng LJ. Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension. Int J Clin Pract. 2007 Nov;61(11):1843-9. doi: 10.1111/j.1742-1241.2007.01585.x. Epub 2007 Sep 20.
    Results Reference
    derived
    PubMed Identifier
    17296414
    Citation
    McVary KT, Monnig W, Camps JL Jr, Young JM, Tseng LJ, van den Ende G. Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double-blind trial. J Urol. 2007 Mar;177(3):1071-7. doi: 10.1016/j.juro.2006.10.055.
    Results Reference
    derived

    Learn more about this trial

    Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)

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