A Study Of The Safety and Efficacy Of Viagra In Men With Erectile Dysfunction Who Do Not Self Identify.
NCT ID: NCT00343200
Last Updated: 2021-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
371 participants
INTERVENTIONAL
2006-07-31
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.
Sildenafil
Viagra (sildenafil citrate)
Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).
Interventions
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Placebo
Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.
Viagra (sildenafil citrate)
Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).
Eligibility Criteria
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Inclusion Criteria
* Men 30 years of age and older
* At least one prespecified risk factor for ED
Exclusion Criteria
* Subjects with a known history of retinitis pigmentosa.
30 Years
MALE
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Huntsville, Alabama, United States
Pfizer Investigational Site
Mesa, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Beverly Hills, California, United States
Pfizer Investigational Site
Huntington Beach, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Santa Rosa, California, United States
Pfizer Investigational Site
Aurora, Colorado, United States
Pfizer Investigational Site
Colorado Springs, Colorado, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Avon, Connecticut, United States
Pfizer Investigational Site
Manchester, Connecticut, United States
Pfizer Investigational Site
Wilmington, Delaware, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Hollywood, Florida, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
Pfizer Investigational Site
Ocala, Florida, United States
Pfizer Investigational Site
Pembroke Pines, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Peoria, Illinois, United States
Pfizer Investigational Site
Fort Wayne, Indiana, United States
Pfizer Investigational Site
Arkansas City, Kansas, United States
Pfizer Investigational Site
Newton, Kansas, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Wichita, Kansas, United States
Pfizer Investigational Site
Wichita, Kansas, United States
Pfizer Investigational Site
Livonia, Michigan, United States
Pfizer Investigational Site
Edina, Minnesota, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
Binghamton, New York, United States
Pfizer Investigational Site
Endwell, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Mogadore, Ohio, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States
Pfizer Investigational Site
Tulsa, Oklahoma, United States
Pfizer Investigational Site
Greer, South Carolina, United States
Pfizer Investigational Site
Simpsonville, South Carolina, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Pfizer Investigational Site
Salt Lake City, Utah, United States
Pfizer Investigational Site
Richmond, Virginia, United States
Pfizer Investigational Site
Spokane, Washington, United States
Pfizer Investigational Site
Tacoma, Washington, United States
Pfizer Investigational Site
Oregon, Wisconsin, United States
Countries
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References
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Cappelleri JC, Chambers R. Addressing Bias in Responder Analysis of Patient-Reported Outcomes. Ther Innov Regul Sci. 2021 Sep;55(5):989-1000. doi: 10.1007/s43441-021-00298-5. Epub 2021 May 27.
Kaminetsky JC, Stecher V, Tseng LJ. Quality of erections by age group in men with erectile dysfunction. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12976. Epub 2017 Sep 11.
Shabsigh R, Kaufman J, Magee M, Creanga D, Russell D, Budhwani M. Lack of awareness of erectile dysfunction in many men with risk factors for erectile dysfunction. BMC Urol. 2010 Nov 5;10:18. doi: 10.1186/1471-2490-10-18.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A1481247
Identifier Type: -
Identifier Source: org_study_id
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