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Trial record 1 of 1 for:    NCT00245596
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Evaluation of the Index of Sexual Life Questionnaire

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ClinicalTrials.gov Identifier: NCT00245596
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE October 27, 2005
First Posted Date  ICMJE October 28, 2005
Last Update Posted Date February 1, 2021
Study Start Date  ICMJE October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2005)
Treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction.
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2005)
To investigate treatment responsiveness of a new quality of sexual life questionnaire for female partners of men with erectile dysfunction.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2006)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2005)
To investigate: the correlation between ED patients' partner quality of sexual life changes and patient's efficacy measures and the correlation between ED patients' partner quality of sexual life changes and patient reported outcomes of self-esteem
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Summary The purpose of the study is to assess the sensibility of the ISL questionnaire.
Detailed Description Not 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 Date Not 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 Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP