Impotence Clinical Trial
Official title:
A Multi-Center, Double-Blind Placebo Controlled, Flexible-Dose Study With An Open-Label Phase To Assess The Efficacy Of Sildenafil Citrate On Erectile Function And Intercourse Satisfaction As Well As To Validate The Sexual Experience Questionnaire And Its Treatment Responsiveness In Men With Erectile Dysfunction
| Verified date | January 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 209 |
| Est. completion date | September 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Documented clinical diagnosis of erectile dysfunction, defined by a score of less than or equal to 25 on the Erectile Dysfunction domain of the International Index of Erectile Function Exclusion Criteria: - Subjects who have been treated with more than 6 doses of sildenafil or any other phosphodiesterase type 5 inhibitor |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Aurora | Colorado |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Des Moines | Iowa |
| United States | Pfizer Investigational Site | Fargo | North Dakota |
| United States | Pfizer Investigational Site | Garden City | New York |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Huntsville | Alabama |
| United States | Pfizer Investigational Site | Jeffersonville | Indiana |
| United States | Pfizer Investigational Site | Kingston | New York |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Ocala | Florida |
| United States | Pfizer Investigational Site | Poughkeepsie | New York |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Shreveport | Louisiana |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Tallahassee | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | |||
| Secondary | 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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