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Evaluation of the Index of Sexual Life Questionnaire

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Amphion-Les-Bains, , France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Impotence
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00245596
Pfizer
Completed
Evaluation of the Index of Sexual Life Questionnaire

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Descriptive Information
Brief Title  ICMJE Evaluation of the Index of Sexual Life Questionnaire
Official Title  ICMJE 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)
Brief SummaryThe purpose of the study is to assess the sensibility of the ISL questionnaire.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Impotence
Intervention  ICMJE Drug: sildenafil
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 27, 2005)
120
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00245596
Other Study ID Numbers  ICMJE A1481210
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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