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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Sildenafil | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF). | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Other questionnaires and variables such as IIEF, SEAR, GEAQ, SEX-Q, QEQ, EDITS, SEP, Event Log, Erection Hardness Grading Score, and Morisky Compliance. | Weeks 8 and 12 | |
| Safety and Tolerability | up to 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Huntsville | Alabama | 35801 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34046875 | Derived | 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. | |
| 28892218 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
| Viagra (sildenafil citrate) | Drug | 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). |
|
| Mesa |
| Arizona |
| 85213 |
| United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85023 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85051 | United States |
| Pfizer Investigational Site | Anaheim | California | 92801 | United States |
| Pfizer Investigational Site | Beverly Hills | California | 90211 | United States |
| Pfizer Investigational Site | Huntington Beach | California | 92648 | United States |
| Pfizer Investigational Site | San Diego | California | 92123 | United States |
| Pfizer Investigational Site | Santa Rosa | California | 95405 | United States |
| Pfizer Investigational Site | Aurora | Colorado | 80012 | United States |
| Pfizer Investigational Site | Colorado Springs | Colorado | 80904 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80212 | United States |
| Pfizer Investigational Site | Avon | Connecticut | 06001 | United States |
| Pfizer Investigational Site | Manchester | Connecticut | 06040 | United States |
| Pfizer Investigational Site | Wilmington | Delaware | 19801 | United States |
| Pfizer Investigational Site | Washington D.C. | District of Columbia | 20010 | United States |
| Pfizer Investigational Site | Hollywood | Florida | 33021 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32216 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34474 | United States |
| Pfizer Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33607 | United States |
| Pfizer Investigational Site | Peoria | Illinois | 61602 | United States |
| Pfizer Investigational Site | Fort Wayne | Indiana | 46825 | United States |
| Pfizer Investigational Site | Arkansas City | Kansas | 67005 | United States |
| Pfizer Investigational Site | Newton | Kansas | 67114 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66215 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67205 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67207 | United States |
| Pfizer Investigational Site | Livonia | Michigan | 48152 | United States |
| Pfizer Investigational Site | Edina | Minnesota | 55435 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89146 | United States |
| Pfizer Investigational Site | Binghamton | New York | 13901 | United States |
| Pfizer Investigational Site | Endwell | New York | 13760 | United States |
| Pfizer Investigational Site | New York | New York | 10016 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45236 | United States |
| Pfizer Investigational Site | Mogadore | Ohio | 44260 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73116 | United States |
| Pfizer Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| Pfizer Investigational Site | Greer | South Carolina | 29651 | United States |
| Pfizer Investigational Site | Simpsonville | South Carolina | 29681 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37203 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84109 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84121 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23294 | United States |
| Pfizer Investigational Site | Spokane | Washington | 99207 | United States |
| Pfizer Investigational Site | Tacoma | Washington | 98405 | United States |
| Pfizer Investigational Site | Oregon | Wisconsin | 53575 | United States |
| 21054874 | Derived | 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. |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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