Back to resultsEvaluation of the Index of Sexual Life Questionnaire
Primary Purpose
Impotence
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Impotence
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00245596
First Posted
October 27, 2005
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00245596
Brief Title
Evaluation of the Index of Sexual Life Questionnaire
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to assess the sensibility of the ISL questionnaire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impotence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sildenafil
Primary Outcome Measure Information:
Title
Treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction.
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Amphion-Les-Bains
Country
France
Facility Name
Pfizer Investigational Site
City
Bordeaux
Country
France
Facility Name
Pfizer Investigational Site
City
La Rochelle
Country
France
Facility Name
Pfizer Investigational Site
City
Lille
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon Cedex 03
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon
Country
France
Facility Name
Pfizer Investigational Site
City
PARIS Cedex 13
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
Country
France
Facility Name
Pfizer Investigational Site
City
Saint-Emilion
Country
France
Facility Name
Pfizer Investigational Site
City
Thionville
Country
France
Facility Name
Pfizer Investigational Site
City
Toulouse
Country
France
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481210&StudyName=Evaluation+of+the+Index+of+Sexual+Life+Questionnaire
Description
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Evaluation of the Index of Sexual Life Questionnaire
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