A Study Of The Safety and Efficacy Of Viagra In Men With Erectile Dysfunction Who Do Not Self Identify.

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ClinicalTrials.gov Identifier: NCT00343200

Recruitment Status : Completed

First Posted : June 22, 2006

Last Update Posted : February 1, 2021

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description

Brief Summary:

To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify as having ED.

Condition or disease	Intervention/treatment	Phase
Impotence	Drug: Placebo Drug: Viagra (sildenafil citrate)	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	371 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Flexible-Dose Study To Assess The Efficacy And Safety Of Viagra (Sildenafil Citrate) In Men With Erectile Dysfunction (ED) Who Do Not Self Identify.
Study Start Date :	July 2006
Actual Study Completion Date :	September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo	Drug: 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.
Experimental: Sildenafil	Drug: 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).

Outcome Measures

Primary Outcome Measures :

To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF). [ Time Frame: Week 8 ]

Secondary Outcome Measures :

Other questionnaires and variables such as IIEF, SEAR, GEAQ, SEX-Q, QEQ, EDITS, SEP, Event Log, Erection Hardness Grading Score, and Morisky Compliance. [ Time Frame: Weeks 8 and 12 ]
Safety and Tolerability [ Time Frame: up to 12 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	30 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men who do not identify as having ED with documented ED
Men 30 years of age and older
At least one prespecified risk factor for ED

Exclusion Criteria:

Subjects currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis
Subjects with a known history of retinitis pigmentosa.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343200

Locations

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United States, Alabama
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Pfizer Investigational Site
Mesa, Arizona, United States, 85213
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023
Pfizer Investigational Site
Phoenix, Arizona, United States, 85051
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
Pfizer Investigational Site
Huntington Beach, California, United States, 92648
Pfizer Investigational Site
San Diego, California, United States, 92123
Pfizer Investigational Site
Santa Rosa, California, United States, 95405
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80012
Pfizer Investigational Site
Colorado Springs, Colorado, United States, 80904
Pfizer Investigational Site
Denver, Colorado, United States, 80212
United States, Connecticut
Pfizer Investigational Site
Avon, Connecticut, United States, 06001
Pfizer Investigational Site
Manchester, Connecticut, United States, 06040
United States, Delaware
Pfizer Investigational Site
Wilmington, Delaware, United States, 19801
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20010
United States, Florida
Pfizer Investigational Site
Hollywood, Florida, United States, 33021
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
Ocala, Florida, United States, 34474
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33024
Pfizer Investigational Site
Tampa, Florida, United States, 33607
United States, Illinois
Pfizer Investigational Site
Peoria, Illinois, United States, 61602
United States, Indiana
Pfizer Investigational Site
Fort Wayne, Indiana, United States, 46825
United States, Kansas
Pfizer Investigational Site
Arkansas City, Kansas, United States, 67005
Pfizer Investigational Site
Newton, Kansas, United States, 67114
Pfizer Investigational Site
Overland Park, Kansas, United States, 66215
Pfizer Investigational Site
Wichita, Kansas, United States, 67205
Pfizer Investigational Site
Wichita, Kansas, United States, 67207
United States, Michigan
Pfizer Investigational Site
Livonia, Michigan, United States, 48152
United States, Minnesota
Pfizer Investigational Site
Edina, Minnesota, United States, 55435
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89146
United States, New York
Pfizer Investigational Site
Binghamton, New York, United States, 13901
Pfizer Investigational Site
Endwell, New York, United States, 13760
Pfizer Investigational Site
New York, New York, United States, 10016
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45236
Pfizer Investigational Site
Mogadore, Ohio, United States, 44260
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73116
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74136
United States, South Carolina
Pfizer Investigational Site
Greer, South Carolina, United States, 29651
Pfizer Investigational Site
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84109
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84121
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23294
United States, Washington
Pfizer Investigational Site
Spokane, Washington, United States, 99207
Pfizer Investigational Site
Tacoma, Washington, United States, 98405
United States, Wisconsin
Pfizer Investigational Site
Oregon, Wisconsin, United States, 53575

Sponsors and Collaborators

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

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Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:	NCT00343200
Other Study ID Numbers:	A1481247
First Posted:	June 22, 2006 Key Record Dates
Last Update Posted:	February 1, 2021
Last Verified:	January 2021

Additional relevant MeSH terms:

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Erectile Dysfunction Genital Diseases, Male Genital Diseases Urogenital Diseases Sexual Dysfunction, Physiological Male Urogenital Diseases Sexual Dysfunctions, Psychological Mental Disorders	Sildenafil Citrate Molecular Mechanisms of Pharmacological Action Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Urological Agents

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