Impotence Clinical Trial
Official title:
An Open Label, Multicenter Study to Measure Treatment Responsiveness of Quality of Sexual Life Questionnaire in the Female Partner of Men With Erectile Dysfunction Treated With Viagra (Sildenafil Citrate)
| NCT number | NCT00245596 |
| Other study ID # | A1481210 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | October 2005 |
| Verified date | January 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the study is to assess the sensibility of the ISL questionnaire.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: ED patient must: - Be male, 18 years of age with no upper age limit; - Have a documented clinical diagnosis of erectile dysfunction confirmed by an Erectile Function (IIEF) score 25. Erectile dysfunction is defined as "the inability to achieve and/or maintain an erection of the penis sufficient to permit satisfactory sexual performance" (Impotence-NIH Consensus Conference, JAMA 1993, 270: 83-90); - Have a stable female partner for at least 6 months prior to screening. Exclusion Criteria: - Have a known hypersensitivity to sildenafil or any component of the study medication; medical history of treatment-related intolerable side effects to sildenafil - Be 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Pfizer Investigational Site | Amphion-Les-Bains | |
| France | Pfizer Investigational Site | Bordeaux | |
| France | Pfizer Investigational Site | La Rochelle | |
| France | Pfizer Investigational Site | Lille | |
| France | Pfizer Investigational Site | Lyon | |
| France | Pfizer Investigational Site | Lyon Cedex 03 | |
| France | Pfizer Investigational Site | Paris | |
| France | Pfizer Investigational Site | PARIS Cedex 13 | |
| France | Pfizer Investigational Site | Saint-Emilion | |
| France | Pfizer Investigational Site | Thionville | |
| France | Pfizer Investigational Site | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction. | |||
| Secondary | The correlation between ED patients' partner quality of sexual life changes and patient's efficacy measures and these changes and patient reported outcomes of self-esteem |
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