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Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00159848
First received: September 8, 2005
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Impotence
 Behavioral: Treatment Optimization Program (educational material)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Effectiveness Of An Educational Program To Improve Patients' Satisfaction Regarding Their Management Of Erectile Dysfunction With Sildenafil

Resource links provided by NLM:

Drug Information available for: Sildenafil
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 8000
Study Start Date: September 2003
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159848

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00159848     History of Changes
Other Study ID Numbers: NRA1481115
Study First Received: September 8, 2005
Last Updated: May 2, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
 Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013