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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00159848
Other study ID # NRA1481115
Secondary ID
Status Completed
Phase Phase 4
First received September 8, 2005
Last updated May 2, 2013
Start date September 2003
Est. completion date September 2003

Study information

Verified date May 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

This study will demonstrate if a treatment optimization program has an impact on the satisfaction with Viagra treatment in men with erectile dysfunction


Recruitment information / eligibility

Status Completed
Enrollment 8000
Est. completion date September 2003
Est. primary completion date September 2003
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Treatment Optimization Program (educational material)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
See also
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Completed NCT00249730 - Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function. Phase 4
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Completed NCT00422578 - Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction Phase 4
Completed NCT00547092 - Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection Phase 4
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Completed NCT00422734 - Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life Phase 3
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Completed NCT00547287 - Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations Phase 3
Completed NCT03830164 - Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer Phase 2
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Completed NCT00150358 - To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension . Phase 4
Completed NCT00159809 - Efficacy Study Measuring The Impact Of Treatment With Viagra On The Depressive Symptoms Of Men With Erectile Dysfunction Phase 4
Completed NCT00143221 - Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH) Phase 4