Status:
COMPLETED
Evaluation of the Index of Sexual Life Questionnaire
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Impotence
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to assess the sensibility of the ISL questionnaire.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00245596
Start Date
October 1 2005
Last Update
February 1 2021
Active Locations (9)
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1
Pfizer Investigational Site
Amphion-les-Bains, France
2
Pfizer Investigational Site
Bordeaux, France
3
Pfizer Investigational Site
La Rochelle, France
4
Pfizer Investigational Site
Lille, France