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Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction - Article


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Impotence


Clinical Trial: Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction

This study is currently recruiting patients.
Verified by Pfizer August 2005

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00141349

Purpose

To determine the onset of action, safety and toleration of different formulations and doses of UK-369,003 in patients with erectile dysfunction. Patients should have been previously treated with PDE5 inhibitors and have been responders to the drugs. Duration of treatment is 4 weeks.
Condition Intervention Phase
Impotence
 Drug: UK-369,003
Phase II

MedlinePlus related topics:  Erectile Dysfunction

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Assess the Time to Onset, Safety, and Toleration of Differing Doses and Combinations of Immediate Release and Modified Release Formulations of UK369,003 in Adult Male Subject with Erectile Dysfunction

Further Study Details: 
Primary Outcomes: The time needed to obtain an erection hard enough to attempt sexual intercourse.
Secondary Outcomes: Proportion of responders based on successful erections; Based on erections hard enough for sexual intercourse; 15, 45 and 60 minutes post dose; Proportion of good responders based on successful erections; International Index of Erectile Function (IIEF): qu
Expected Total Enrollment:  300

Study start: January 2005

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Male
Criteria

Inclusion Criteria:

  • Erectile dysfunction as defined by DSM-IV. Patients should have been PDE5 inhibitor respondents

Exclusion Criteria:

  • Alpha blockers and Nitrates of any preparation

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00141349

Pfizer CT.gov Call Center      1-800-718-1021 

Alabama
      Pfizer Investigational Site, Birmingham,  Alabama,  35205,  United States; Completed

      Pfizer Investigational Site, Birmingham,  Alabama,  35215,  United States; Completed

      Pfizer Investigational Site, Birmingham,  Alabama,  35209-5603,  United States; Completed

Arizona
      Pfizer Investigational Site, Mesa,  Arizona,  85201,  United States; Completed

      Pfizer Investigational Site, Mesa,  Arizona,  85213,  United States; Completed

      Pfizer Investigational Site, Tempe,  Arizona,  85282,  United States; Completed

      Pfizer Investigational Site, Mesa,  Arizona,  85206,  United States; Completed

California
      Pfizer Investigational Site, Beverly Hills,  California,  90212,  United States; Completed

      Pfizer Investigational Site, San Bernardino,  California,  92404,  United States; Recruiting

      Pfizer Investigational Site, Torrance,  California,  90505,  United States; Completed

Connecticut
      Pfizer Investigational Site, Waterbury,  Connecticut,  06708,  United States; Completed

Florida
      Pfizer Investigational Site, Aventura,  Florida,  33180,  United States; Recruiting

      Pfizer Investigational Site, Pembroke Pines,  Florida,  33028,  United States; Recruiting

      Pfizer Investigational Site, West Palm Beach,  Florida,  33407,  United States; Completed

      Pfizer Investigational Site, St. Petersburg,  Florida,  33709,  United States; Completed

Indiana
      Pfizer Investigational Site, Fort Wayne,  Indiana,  46825,  United States; Completed

      Pfizer Investigational Site, Evansville,  Indiana,  47714,  United States; Completed

      Pfizer Investigational Site, Jeffersonville,  Indiana,  47130,  United States; Completed

Louisiana
      Pfizer Investigational Site, Metairie,  Louisiana,  70002,  United States; Recruiting

      Pfizer Investigational Site, Metairie,  Louisiana,  70006,  United States; Recruiting

Massachusetts
      Pfizer Investigational Site, Milford,  Massachusetts,  01757,  United States; Recruiting

Missouri
      Pfizer Investigational Site, Kansas City,  Missouri,  64114,  United States; Completed

New Jersey
      Pfizer Investigational Site, New Brunswick,  New Jersey,  08903,  United States; Completed

New York
      Pfizer Investigational Site, New York,  New York,  10016,  United States; Completed

      Pfizer Investigational Site, Albany,  New York,  12206,  United States; Recruiting

      Pfizer Investigational Site, Endwell,  New York,  13760,  United States; Completed

North Carolina
      Pfizer Investigational Site, Winston Salem,  North Carolina,  27103,  United States; Recruiting

      Pfizer Investigational Site, Raleigh,  North Carolina,  27609,  United States; Completed

      Pfizer Investigational Site, Raleigh,  North Carolina,  27609-7216,  United States; Completed

Ohio
      Pfizer Investigational Site, Cleveland,  Ohio,  44122,  United States; Completed

      Pfizer Investigational Site, Cincinnati,  Ohio,  45212,  United States; No longer recruiting

Texas
      Pfizer Investigational Site, Bryan,  Texas,  77802,  United States; Recruiting

      Pfizer Investigational Site, Sugar Land,  Texas,  77478,  United States; Recruiting

Utah
      Pfizer Investigational Site, Salt Lake City,  Utah,  84109,  United States; Completed

      Pfizer Investigational Site, West Jordan,  Utah,  84088,  United States; Completed

Virginia
      Pfizer Investigational Site, Norfolk,  Virginia,  23502,  United States; Recruiting

      Pfizer Investigational Site, Richmond,  Virginia,  23294,  United States; Recruiting

Wisconsin
      Pfizer Investigational Site, Milwaukee,  Wisconsin,  53209,  United States; Completed

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

More Information

Study ID Numbers:  A3711029
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00141349
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06


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Page Updated: September 30, 2005
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