Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction
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
1 other identifier
interventional
300
1 country
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2005
Shorter than P25 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedJuly 25, 2006
January 1, 2006
August 30, 2005
July 23, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
The time needed to obtain an erection hard enough to attempt sexual intercourse.
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- Erectile dysfunction as defined by DSM-IV. Patients should have been PDE5 inhibitor respondents
You may not qualify if:
- Alpha blockers and Nitrates of any preparation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (39)
Pfizer Investigational Site
Birmingham, Alabama, 35205, United States
Pfizer Investigational Site
Birmingham, Alabama, 35209-5603, United States
Pfizer Investigational Site
Birmingham, Alabama, 35215, United States
Pfizer Investigational Site
Mesa, Arizona, 85201, United States
Pfizer Investigational Site
Mesa, Arizona, 85206, United States
Pfizer Investigational Site
Mesa, Arizona, 85213, United States
Pfizer Investigational Site
Tempe, Arizona, 85282, United States
Pfizer Investigational Site
Beverly Hills, California, 90212, United States
Pfizer Investigational Site
San Bernardino, California, 92404, United States
Pfizer Investigational Site
Torrance, California, 90505, United States
Pfizer Investigational Site
Waterbury, Connecticut, 06708, United States
Pfizer Investigational Site
Aventura, Florida, 33180, United States
Pfizer Investigational Site
Pembroke Pines, Florida, 33028, United States
Pfizer Investigational Site
St. Petersburg, Florida, 33709, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33407, United States
Pfizer Investigational Site
Evansville, Indiana, 47714, United States
Pfizer Investigational Site
Fort Wayne, Indiana, 46825, United States
Pfizer Investigational Site
Jeffersonville, Indiana, 47130, United States
Pfizer Investigational Site
Metairie, Louisiana, 70002, United States
Pfizer Investigational Site
Metairie, Louisiana, 70006, United States
Pfizer Investigational Site
Milford, Massachusetts, 01757, United States
Pfizer Investigational Site
Kansas City, Missouri, 64114, United States
Pfizer Investigational Site
New Brunswick, New Jersey, 08903, United States
Pfizer Investigational Site
Albany, New York, 12206, United States
Pfizer Investigational Site
Endwell, New York, 13760, United States
Pfizer Investigational Site
New York, New York, 10016, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27609-7216, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27609, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103, United States
Pfizer Investigational Site
Beachwood, Ohio, 44122-5402, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45212, United States
Pfizer Investigational Site
Cleveland, Ohio, 44122, United States
Pfizer Investigational Site
Bryan, Texas, 77802, United States
Pfizer Investigational Site
Sugar Land, Texas, 77478, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84109, United States
Pfizer Investigational Site
West Jordan, Utah, 84088, United States
Pfizer Investigational Site
Norfolk, Virginia, 23502, United States
Pfizer Investigational Site
Richmond, Virginia, 23294, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
February 1, 2005
Study Completion
August 1, 2005
Last Updated
July 25, 2006
Record last verified: 2006-01