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Evaluation of the Index of Sexual Life Questionnaire

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00245596
First received: October 27, 2005
Last updated: February 22, 2008
Last verified: February 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Impotence
 Drug: sildenafil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

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

Estimated Enrollment: 120
Study Start Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245596

Locations
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, France
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00245596     History of Changes
Other Study ID Numbers: A1481210
Study First Received: October 27, 2005
Last Updated: February 22, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013