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To evaluate the effectiveness of sildenafil on erectile function and intercourse satisfaction in men with ED as well as to validate the new Sexual Experience Questionnaire which incorporates functional and emotional elements of a man's sexual experience into one comprehensive questionnaire.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildenafil citrate | Drug | |||
| placebo for sildenafil citrate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoints are: The changes from baseline to Visit 5 (Week 10) of the Erectile Function (Questions 1-5, 15) Intercourse Satisfaction domains (Questions 6-8) of the International Index of Erectile Function (IIEF). |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline to Visit 4 (Week 6), Visit 5 (Week 10) and Visit 7 (Week 16) in the domains and total score as well as the individual questions of the Sexual Experience Questionnaire (SEX-Q) |
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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 | United States | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 19143915 | Derived | Cappelleri JC, Bushmakin AG, Symonds T, Schnetzler G. Scoring correspondence in outcomes related to erectile dysfunction treatment on a 4-point scale (SCORE-4). J Sex Med. 2009 Mar;6(3):809-19. doi: 10.1111/j.1743-6109.2008.01155.x. Epub 2009 Jan 7. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| San Diego |
| California |
| United States |
| Pfizer Investigational Site | Aurora | Colorado | United States |
| Pfizer Investigational Site | Miami | Florida | United States |
| Pfizer Investigational Site | Ocala | Florida | United States |
| Pfizer Investigational Site | Tallahassee | Florida | 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 | Garden City | 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 | Fargo | North Dakota | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | United States |
| Pfizer Investigational Site | Houston | Texas | United States |
| Pfizer Investigational Site | San Antonio | Texas | United States |
| Pfizer Investigational Site | Seattle | Washington | United States |
| Pfizer Investigational Site | Spokane | Washington | United States |
| 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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