- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00159848
Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra
May 2, 2013 updated by: Pfizer
Effectiveness Of An Educational Program To Improve Patients' Satisfaction Regarding Their Management Of Erectile Dysfunction With Sildenafil
This study will demonstrate if a treatment optimization program has an impact on the satisfaction with Viagra treatment in men with erectile dysfunction
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
8000
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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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
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Secondary Outcome Measures
Outcome Measure |
|---|
|
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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Primary Completion (Actual)
September 1, 2003
Study Completion (Actual)
September 1, 2003
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
May 3, 2013
Last Update Submitted That Met QC Criteria
May 2, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NRA1481115
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.