NCT00159848

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

Same day

First QC Date

September 8, 2005

Last Update Submit

May 2, 2013

Conditions

Impotence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

Treatment Optimization Program (educational material)BEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2003

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

May 3, 2013

Record last verified: 2013-05