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Evaluation of the Index of Sexual Life Questionnaire - Article


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Erectile Dysfunction

ED; Erectile Disorder; Erectile Disorder (Impotence)


Clinical Trial: Evaluation of the Index of Sexual Life Questionnaire

This study is not yet open for patient recruitment.
Verified by Pfizer December 2005

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00245596

Purpose

The purpose of the study is to assess the sensibility of the ISL questionnaire.
Condition Intervention Phase
Erectile Dysfunction
 Drug: sildenafil
Phase IV

MedlinePlus related topics:  Erectile Dysfunction

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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)

Further study details as provided by Pfizer:
Primary Outcomes: Treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction.
Secondary Outcomes: 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
Expected Total Enrollment:  120

Study start: December 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

ED patient must:

  • Be male, ³ 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;;

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00245596


Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

More Information

Study ID Numbers:  A1481210
Last Updated:  December 8, 2005
Record first received:  October 27, 2005
ClinicalTrials.gov Identifier:  NCT00245596
Health Authority: France: AFSSAPS
ClinicalTrials.gov processed this record on 2006-01-10


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Page Updated: September 30, 2005
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