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Trial record 1 of 1 for:    NCT00245258
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Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction

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ClinicalTrials.gov Identifier: NCT00245258
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : October 6, 2006
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE October 25, 2005
First Posted Date  ICMJE October 27, 2005
Last Update Posted Date October 6, 2006
Study Start Date  ICMJE November 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2005)
The primary endpoint is the change from baseline to Visit 4 (Week 8) in the IIEF Erectile Function (EF) domain score.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00245258 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2005)
The change from baseline to visit 6 (wk 12) in the IIEF-EF domain; the change from baseline to visit 4 (wk 8) and visit 6 (wk 12) in the domains and total score as well as the individual questions of the sexual experience questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction
Official Title  ICMJE A Multicenter, Double-Blind Placebo Controlled, Fixed Dose Study With An Open-Label, Flexible Dose Phase To Assess The Efficacy Of Sildenafil Citrate In Providing A Better Sexual Experience Including Quality Of Erections And Satisfaction In Men With Erectile Dysfunction
Brief Summary

The study objective is to:

  1. To evaluate the effect of sildenafil citrate versus placebo on the IIEF_EF Domain at the end of the double-blind phase
  2. To assess the relationship between treatment with sildenafil citrate or placebo and responses to the Quality of Erection Questionnaire (QEQ) and Sexual Experience Questionnaire (SEX_Q).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Impotence
Intervention  ICMJE Drug: Sildenafil Citrate
Study Arms  ICMJE Not Provided
Publications *

*   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 25, 2005)
312
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male subjects aged 18-65.
  • Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.)

Exclusion Criteria:

  • Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction [Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening].
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (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 Korea, Republic of,   Russian Federation,   Spain,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00245258
Other Study ID Numbers  ICMJE A1481239
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2006

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