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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00245596
Other study ID # A1481210
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2005

Study information

Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to assess the sensibility of the ISL questionnaire.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
sildenafil


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

France, 

Outcome

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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