Evaluation of the Index of Sexual Life Questionnaire
Phase 4
Completed
- Conditions
- Impotence
- Registration Number
- NCT00245596
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The purpose of the study is to assess the sensibility of the ISL questionnaire.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 120
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇫🇷Toulouse, France