Clinical trial NCT00301262: Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impotence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2006-03-10
Enrollment: 183
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Men above age of majority
* Mild erectile dysfunction (IIEF-EF 22-25) and sexual dissatisfaction (IIEF-OS 7 or less)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)
timeFrame: Week 8
Secondary outcomes:
measure: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index
timeFrame: Week 8, Week 14
measure: Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score
timeFrame: Week 8
measure: Patient Reported Erectile Function Assessment (PREFA) Total Score
timeFrame: Week 8, Week 14
measure: Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
timeFrame: Week 8
measure: Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
timeFrame: Week 8
measure: Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
timeFrame: Week 8
measure: Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
timeFrame: Week 8
measure: Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
timeFrame: Week 8
measure: International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
timeFrame: Week 8, Week 14
measure: International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
timeFrame: Week 8, Week 14
measure: International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
timeFrame: Week 8, Week 14
measure: International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
timeFrame: Week 8, Week 14
measure: International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
timeFrame: Week 8, Week 14
measure: Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score
timeFrame: Week 8
measure: Erectile Distress Scale (EDS) Total Score
timeFrame: Week 8, Week 14
measure: Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score
timeFrame: Week 8
measure: Quality of Erection Questionnaire (QEQ) Total Score
timeFrame: Week 8, Week 14
measure: Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
timeFrame: Week 8, Week 14
measure: Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
timeFrame: Week 8, Week 14
measure: Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
timeFrame: Week 8, Week 14
measure: Percentage of Occasions of Successful Intercourse (Event Log)
timeFrame: Baseline to Week 8
measure: Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)
timeFrame: Baseline to Week 8
measure: Percentage of Occasions of Successful Intercourse (Event Log)
timeFrame: Week 8 to Week 14
measure: Percentage of Occasions of Ejaculation and/or Orgasm Event Log
timeFrame: Week 8 to Week 14
measure: Change From Baseline to Week 8 in Analog Scales- Firmness
timeFrame: baseline to Week 8
measure: Change From Baseline to Week 8 in Analog Scales- Maintenance
timeFrame: baseline to Week 8
measure: Change From Baseline to Week 8 in Analog Scales- Reliability
timeFrame: baseline to Week 8
measure: Change From Baseline to Week 8 in Analog Scales- General Sexual Performance
timeFrame: baseline to week 8
measure: Analog Scales- Firmness
timeFrame: Week 8, Week 14
measure: Analog Scales- Maintenance
timeFrame: Week 8, Week 14
measure: Analog Scales- Reliability
timeFrame: Week 8, Week 14
measure: Analog Scales- General Sexual Performance
timeFrame: Week 8, Week 14
measure: Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1
timeFrame: Week 8 to Week 14
measure: Shift in Responder Rate From Week 8 to Week 14 for GEQ2
timeFrame: Week 8 to Week 14
measure: Shift in Responder Rate From Week 8 to Week 14 for GEQ3
timeFrame: Week 8 to Week 14
measure: Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0
timeFrame: Baseline to <Week 8 and Week 8 to <=Week 14
measure: Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1
timeFrame: Baseline to <= Week 14
measure: Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2
timeFrame: Baseline to <Week 8 and Week 8 to <=Week 14
measure: Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3
timeFrame: Baseline to <Week 8 and Week 8 to <=Week 14
measure: Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4
timeFrame: Baseline to <Week 8 and Week 8 to <=Week 14
measure: Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4
timeFrame: Baseline to <Week 8 and Week 8 to <=Week 14
measure: Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0
timeFrame: Baseline to <Week 8 and Week 8 to <=Week 14
measure: Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1
timeFrame: Baseline to <Week 8 and Week 8 to <=Week 14
measure: Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2
timeFrame: Baseline to <Week 8 and Week 8 to <=Week 14
measure: Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3
timeFrame: Baseline to <Week 8 and Week 8 to <=Week 14
measure: Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4
timeFrame: Baseline to <Week 8 and Week 8 to <=Week 14
measure: Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4
timeFrame: Baseline to <Week 8 and Week 8 to <=Week 14
measure: Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections
timeFrame: Baseline to <Week 8 and Week 8 to <=Week 14
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Langley
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Surrey
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Bay Roberts
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Corunna
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: L'Ancienne-Lorette
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montréal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St. Leonard
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.