Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose
Multicenter Randomized Double-Blind, Placebo-Controlled, Fixed-Dose Parallel Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose - II
1 other identifier
interventional
250
1 country
25
Brief Summary
Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2005
Shorter than P25 for phase_4
25 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
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedFebruary 1, 2021
January 1, 2021
9 months
August 31, 2005
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra.
Secondary Outcomes (1)
Proportion (as above) of patients at various endpoints. Other questionnaires such as SEP, IIEF.
Interventions
Eligibility Criteria
You may qualify if:
- Men 18-70 years of age
- Documented clinical diagnosis of erectile dysfunction of at least 3 months duration.
You may not qualify if:
- Subjects with penile implants
- Subjects with a known history of retinitis pigmentosa.
- Subjects, due to the requirement of 100 mg dosage, who are receiving concomitant treatment with the potent CYP3A4 inhibitor ritonavir.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Homewood, Alabama, United States
Pfizer Investigational Site
Hoover, Alabama, United States
Pfizer Investigational Site
Huntsville, Alabama, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
La Mesa, California, United States
Pfizer Investigational Site
Newport Beach, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Aurora, Colorado, United States
Pfizer Investigational Site
Gainesville, Florida, United States
Pfizer Investigational Site
South Miami, Florida, United States
Pfizer Investigational Site
Tallahassee, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Fort Wayne, Indiana, United States
Pfizer Investigational Site
Jeffersonville, Indiana, United States
Pfizer Investigational Site
Des Moines, Iowa, United States
Pfizer Investigational Site
Shreveport, Louisiana, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
Bay Shore, New York, United States
Pfizer Investigational Site
Kingston, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Poughkeepsie, New York, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Spokane, Washington, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
August 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
February 1, 2021
Record last verified: 2021-01