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Trial record 1 of 1 for:    NCT00159848
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Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra

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ClinicalTrials.gov Identifier: NCT00159848
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 3, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date May 3, 2013
Study Start Date  ICMJE September 2003
Actual Primary Completion Date September 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
Assess the impact of a sildenafil educational program versus usual care on subjects' satisfaction regarding their management of ED with sildenafil as assessed through the validated EDITS questionnnaire after 3 months of treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00159848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2005)
Describe the relationship between the administration of an educational program and the effectiveness of sildenafil; Evaluate the educational program as a tool to help physicians in their management of ED; Estimate the intracluster correlation coefficient
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
Describe the relationship between the administration of an educational program and the effectiveness of sildenafil as measured by the SHIM. Assess the effectiveness of the educational program on renewal/refill prescription rate. Describe sildenafil users
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra
Official Title  ICMJE Effectiveness Of An Educational Program To Improve Patients' Satisfaction Regarding Their Management Of Erectile Dysfunction With Sildenafil
Brief Summary This study will demonstrate if a treatment optimization program has an impact on the satisfaction with Viagra treatment in men with erectile dysfunction
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Impotence
Intervention  ICMJE Behavioral: Treatment Optimization Program (educational material)
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: September 8, 2005)
8000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2003
Actual Primary Completion Date September 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male subjects above age of majority for whom sildenafil is prescribed for the first time within the usual practice of medicine

Exclusion Criteria:

  • Male subjects who have used any ED medical treatments over the last month, with the exception of testosterone and/or herbal therapies
  • Subjects who do not have the possibility of viewing the video either through a computer, VCR or a DVD
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00159848
Other Study ID Numbers  ICMJE NRA1481115
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2013

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