search
Back to results

Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied

Primary Purpose

Impotence

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Viagra (Sildenafil citrate)
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impotence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index
Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score
adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.
Patient Reported Erectile Function Assessment (PREFA) Total Score
PREFA Total Score: 8 = worst, 32 = best.
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).
International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score
adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Erectile Distress Scale (EDS) Total Score
Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score
adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
Quality of Erection Questionnaire (QEQ) Total Score
QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
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)
GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.
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)
GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.
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)
GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never.
Percentage of Occasions of Successful Intercourse (Event Log)
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Percentage of Occasions of Successful Intercourse (Event Log)
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Percentage of Occasions of Ejaculation and/or Orgasm Event Log
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Change From Baseline to Week 8 in Analog Scales- Firmness
mean change - scale of 0 (worst) to 10 (best).
Change From Baseline to Week 8 in Analog Scales- Maintenance
mean change - scale of 0 (worst) to 10 (best).
Change From Baseline to Week 8 in Analog Scales- Reliability
mean change - scale of 0 (worst) to 10 (best).
Change From Baseline to Week 8 in Analog Scales- General Sexual Performance
mean change - scale of 0 (worst) to 10 (best)
Analog Scales- Firmness
mean - scale of 0 (worst) to 10 (best)
Analog Scales- Maintenance
mean - scale of 0 (worst) to 10 (best)
Analog Scales- Reliability
mean - scale of 0 (worst) to 10 (best)
Analog Scales- General Sexual Performance
mean - scale of 0 (worst) to 10 (best)
Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1
GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections? Responder was defined as answering Yes to GEQ 1.
Shift in Responder Rate From Week 8 to Week 14 for GEQ2
GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes to GEQ 2.
Shift in Responder Rate From Week 8 to Week 14 for GEQ3
GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0
Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1
Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2
Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3
Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4
Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4
Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0
Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1
Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2
Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3
Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4
Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4
Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections
Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.

Full Information

First Posted
March 7, 2006
Last Updated
January 28, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00301262
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impotence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Viagra (Sildenafil citrate)
Primary Outcome Measure Information:
Title
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)
Description
adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index
Description
Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Time Frame
Week 8, Week 14
Title
Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score
Description
adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.
Time Frame
Week 8
Title
Patient Reported Erectile Function Assessment (PREFA) Total Score
Description
PREFA Total Score: 8 = worst, 32 = best.
Time Frame
Week 8, Week 14
Title
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Description
adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Time Frame
Week 8
Title
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Description
adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Time Frame
Week 8
Title
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
Description
adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).
Time Frame
Week 8
Title
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Description
adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Time Frame
Week 8
Title
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
Description
adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).
Time Frame
Week 8
Title
International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Description
Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Time Frame
Week 8, Week 14
Title
International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Description
Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Time Frame
Week 8, Week 14
Title
International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
Description
Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Time Frame
Week 8, Week 14
Title
International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Description
Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Time Frame
Week 8, Week 14
Title
International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
Description
Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Time Frame
Week 8, Week 14
Title
Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score
Description
adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Time Frame
Week 8
Title
Erectile Distress Scale (EDS) Total Score
Description
Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Time Frame
Week 8, Week 14
Title
Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score
Description
adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
Time Frame
Week 8
Title
Quality of Erection Questionnaire (QEQ) Total Score
Description
QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
Time Frame
Week 8, Week 14
Title
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)
Description
GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.
Time Frame
Week 8, Week 14
Title
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)
Description
GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering "Yes". % of responders/non-responders was calculated based on subjects who attempted intercourse.
Time Frame
Week 8, Week 14
Title
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)
Description
GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never.
Time Frame
Week 8, Week 14
Title
Percentage of Occasions of Successful Intercourse (Event Log)
Description
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to Week 8
Title
Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)
Description
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to Week 8
Title
Percentage of Occasions of Successful Intercourse (Event Log)
Description
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Week 8 to Week 14
Title
Percentage of Occasions of Ejaculation and/or Orgasm Event Log
Description
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Week 8 to Week 14
Title
Change From Baseline to Week 8 in Analog Scales- Firmness
Description
mean change - scale of 0 (worst) to 10 (best).
Time Frame
baseline to Week 8
Title
Change From Baseline to Week 8 in Analog Scales- Maintenance
Description
mean change - scale of 0 (worst) to 10 (best).
Time Frame
baseline to Week 8
Title
Change From Baseline to Week 8 in Analog Scales- Reliability
Description
mean change - scale of 0 (worst) to 10 (best).
Time Frame
baseline to Week 8
Title
Change From Baseline to Week 8 in Analog Scales- General Sexual Performance
Description
mean change - scale of 0 (worst) to 10 (best)
Time Frame
baseline to week 8
Title
Analog Scales- Firmness
Description
mean - scale of 0 (worst) to 10 (best)
Time Frame
Week 8, Week 14
Title
Analog Scales- Maintenance
Description
mean - scale of 0 (worst) to 10 (best)
Time Frame
Week 8, Week 14
Title
Analog Scales- Reliability
Description
mean - scale of 0 (worst) to 10 (best)
Time Frame
Week 8, Week 14
Title
Analog Scales- General Sexual Performance
Description
mean - scale of 0 (worst) to 10 (best)
Time Frame
Week 8, Week 14
Title
Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1
Description
GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections? Responder was defined as answering Yes to GEQ 1.
Time Frame
Week 8 to Week 14
Title
Shift in Responder Rate From Week 8 to Week 14 for GEQ2
Description
GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes to GEQ 2.
Time Frame
Week 8 to Week 14
Title
Shift in Responder Rate From Week 8 to Week 14 for GEQ3
Description
GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never.
Time Frame
Week 8 to Week 14
Title
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0
Description
Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to <Week 8 and Week 8 to <=Week 14
Title
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1
Description
Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to <= Week 14
Title
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2
Description
Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to <Week 8 and Week 8 to <=Week 14
Title
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3
Description
Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to <Week 8 and Week 8 to <=Week 14
Title
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4
Description
Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to <Week 8 and Week 8 to <=Week 14
Title
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4
Description
Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to <Week 8 and Week 8 to <=Week 14
Title
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0
Description
Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to <Week 8 and Week 8 to <=Week 14
Title
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1
Description
Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to <Week 8 and Week 8 to <=Week 14
Title
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2
Description
Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to <Week 8 and Week 8 to <=Week 14
Title
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3
Description
Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to <Week 8 and Week 8 to <=Week 14
Title
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4
Description
Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to <Week 8 and Week 8 to <=Week 14
Title
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4
Description
Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to <Week 8 and Week 8 to <=Week 14
Title
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections
Description
Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time Frame
Baseline to <Week 8 and Week 8 to <=Week 14

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2L 1K8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 4R6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 4B9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Langley
State/Province
British Columbia
ZIP/Postal Code
V3A 4H9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1N1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1K3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2T1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Bay Roberts
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A0A 1G0
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Corunna
State/Province
Ontario
ZIP/Postal Code
N0N 1G0
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 4A3
Country
Canada
Facility Name
Pfizer Investigational Site
City
L'Ancienne-Lorette
State/Province
Quebec
ZIP/Postal Code
G2E 2X1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1N8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3S 1Z1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 1N8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. Leonard
State/Province
Quebec
ZIP/Postal Code
H1S 3A9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28892218
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1481238&StudyName=Impact%20Of%20Viagra%20On%20Sexual%20Satisfaction%20Of%20Men%20With%20Mild%20Erectile%20Dysfunction%20Who%20Are%20Sexually%20Dissatisfied
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied

We'll reach out to this number within 24 hrs