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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
183
Pfizer Investigational Site
Calgary, Alberta, Canada
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).
Time frame: Week 8
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).
Time frame: Week 8, Week 14
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.
Time frame: Week 8
Patient Reported Erectile Function Assessment (PREFA) Total Score
PREFA Total Score: 8 = worst, 32 = best.
Time frame: 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
adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Time frame: Week 8
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).
Time frame: Week 8
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
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Pfizer Investigational Site
Calgary, Alberta, Canada
Pfizer Investigational Site
Edmonton, Alberta, Canada
Pfizer Investigational Site
Langley, British Columbia, Canada
Pfizer Investigational Site
Surrey, British Columbia, Canada
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
Victoria, British Columbia, Canada
Pfizer Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada
Pfizer Investigational Site
Halifax, Nova Scotia, Canada
...and 16 more locations
adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).
Time frame: Week 8
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).
Time frame: Week 8
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).
Time frame: Week 8
International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Time frame: Week 8, Week 14
International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Time frame: Week 8, Week 14
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).
Time frame: Week 8, Week 14
International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Time frame: Week 8, Week 14
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).
Time frame: Week 8, Week 14
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.
Time frame: Week 8
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.
Time frame: Week 8, Week 14
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).
Time frame: Week 8
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).
Time frame: Week 8, Week 14
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.
Time frame: Week 8, Week 14
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.
Time frame: Week 8, Week 14
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.
Time frame: Week 8, Week 14
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.
Time frame: Baseline to Week 8
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.
Time frame: Baseline to Week 8
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.
Time frame: Week 8 to Week 14
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.
Time frame: Week 8 to Week 14
Change From Baseline to Week 8 in Analog Scales- Firmness
mean change - scale of 0 (worst) to 10 (best).
Time frame: baseline to Week 8
Change From Baseline to Week 8 in Analog Scales- Maintenance
mean change - scale of 0 (worst) to 10 (best).
Time frame: baseline to Week 8
Change From Baseline to Week 8 in Analog Scales- Reliability
mean change - scale of 0 (worst) to 10 (best).
Time frame: baseline to Week 8
Change From Baseline to Week 8 in Analog Scales- General Sexual Performance
mean change - scale of 0 (worst) to 10 (best)
Time frame: baseline to week 8
Analog Scales- Firmness
mean - scale of 0 (worst) to 10 (best)
Time frame: Week 8, Week 14
Analog Scales- Maintenance
mean - scale of 0 (worst) to 10 (best)
Time frame: Week 8, Week 14
Analog Scales- Reliability
mean - scale of 0 (worst) to 10 (best)
Time frame: Week 8, Week 14
Analog Scales- General Sexual Performance
mean - scale of 0 (worst) to 10 (best)
Time frame: Week 8, Week 14
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.
Time frame: Week 8 to Week 14
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.
Time frame: Week 8 to Week 14
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.
Time frame: Week 8 to Week 14
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.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
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.
Time frame: Baseline to <= Week 14
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.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
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.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
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.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
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.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
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.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
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.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
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.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
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.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
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.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
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.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
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.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14