Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied
A Multi-Center, Parallel Group, Flexible Dose Trial With A Double-Blind, Randomized, Placebo-Controlled Phase Followed By An Open-Label Phase To Assess The Impact Of Viagra On The Sexual Satisfaction Of Men With Mild Erectile Dysfunction
1 other identifier
interventional
183
1 country
26
Brief Summary
Men's quality of life (QoL) is potentially affected by mild erectile dysfunction (ED) to the same extent as it is by moderate and severe ED. This study will provide controlled clinical data measuring efficacy, QoL parameters and satisfaction changes in men with mild ED treated with Viagra versus those treated with a placebo. With an open-label extension, this study will also provide all study subjects the opportunity to receive the active drug treatment for 6 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2005
26 active sites
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
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 7, 2006
CompletedFirst Posted
Study publicly available on registry
March 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedResults Posted
Study results publicly available
December 9, 2008
CompletedFebruary 1, 2021
January 1, 2021
1.8 years
March 7, 2006
November 12, 2008
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)
adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Week 8
Secondary Outcomes (48)
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index
Week 8, Week 14
Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score
Week 8
Patient Reported Erectile Function Assessment (PREFA) Total Score
Week 8, Week 14
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Week 8
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Week 8
- +43 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Men above age of majority
- Mild erectile dysfunction (IIEF-EF 22-25) and sexual dissatisfaction (IIEF-OS 7 or less)
You may not qualify if:
- Use of more than 4 doses of any PDE5 inhibitor in the past 12 weeks and use of any PDE5 inhibitor in the past 4 weeks
- Subjects currently taking any other commercially available drug or non-drug treatment for ED
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.lead
- Pfizercollaborator
Study Sites (26)
Pfizer Investigational Site
Calgary, Alberta, T2L 1K8, Canada
Pfizer Investigational Site
Calgary, Alberta, T2V 4R6, Canada
Pfizer Investigational Site
Edmonton, Alberta, T5H 4B9, Canada
Pfizer Investigational Site
Langley, British Columbia, V3A 4H9, Canada
Pfizer Investigational Site
Surrey, British Columbia, V3V 1N1, Canada
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 1K3, Canada
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 2T1, Canada
Pfizer Investigational Site
Victoria, British Columbia, V8T 5G1, Canada
Pfizer Investigational Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 3A7, Canada
Pfizer Investigational Site
Barrie, Ontario, L4M 7G1, Canada
Pfizer Investigational Site
Corunna, Ontario, N0N 1G0, Canada
Pfizer Investigational Site
Kingston, Ontario, K7L 3J7, Canada
Pfizer Investigational Site
London, Ontario, N6A 4V2, Canada
Pfizer Investigational Site
Oakville, Ontario, L6H 3P1, Canada
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3, Canada
Pfizer Investigational Site
Toronto, Ontario, M5T 2S8, Canada
Pfizer Investigational Site
Toronto, Ontario, M6A 3B5, Canada
Pfizer Investigational Site
Chicoutimi, Quebec, G7H 4A3, Canada
Pfizer Investigational Site
L'Ancienne-Lorette, Quebec, G2E 2X1, Canada
Pfizer Investigational Site
Montreal, Quebec, H2L 5B1, Canada
Pfizer Investigational Site
Montreal, Quebec, H2X 1N8, Canada
Pfizer Investigational Site
Montreal, Quebec, H3S 1Z1, Canada
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3, Canada
Pfizer Investigational Site
Saint-LĂ©onard, Quebec, H1S 3A9, Canada
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 1Z1, Canada
Related Publications (1)
Kaminetsky JC, Stecher V, Tseng LJ. Quality of erections by age group in men with erectile dysfunction. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12976. Epub 2017 Sep 11.
PMID: 28892218DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2006
First Posted
March 10, 2006
Study Start
November 1, 2005
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
February 1, 2021
Results First Posted
December 9, 2008
Record last verified: 2021-01