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

Impotence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301262
• Other study ID #: A1481238
• Status: Completed
• Phase: Phase 4
• Start date: November 2005
• Est. completion date: September 2007

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Impotence

Intervention

Drug:
• Viagra (Sildenafil citrate)

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Barrie	Ontario
Canada	Pfizer Investigational Site	Bay Roberts	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Chicoutimi	Quebec
Canada	Pfizer Investigational Site	Corunna	Ontario
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Kingston	Ontario
Canada	Pfizer Investigational Site	L'Ancienne-Lorette	Quebec
Canada	Pfizer Investigational Site	Langley	British Columbia
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montréal	Quebec
Canada	Pfizer Investigational Site	Oakville	Ontario
Canada	Pfizer Investigational Site	Pointe-Claire	Quebec
Canada	Pfizer Investigational Site	Sarnia	Ontario
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	St. Leonard	Quebec
Canada	Pfizer Investigational Site	Surrey	British Columbia
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Week 8, Week 14
Secondary	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.	Week 8
Secondary	Patient Reported Erectile Function Assessment (PREFA) Total Score	PREFA Total Score: 8 = worst, 32 = best.	Week 8, Week 14
Secondary	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).	Week 8
Secondary	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).	Week 8
Secondary	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).	Week 8
Secondary	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).	Week 8
Secondary	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).	Week 8
Secondary	International Index of Erectile Function (IIEF) Domain Scores- Erectile Function	Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).	Week 8, Week 14
Secondary	International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function	Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).	Week 8, Week 14
Secondary	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).	Week 8, Week 14
Secondary	International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction	Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).	Week 8, Week 14
Secondary	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).	Week 8, Week 14
Secondary	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.	Week 8
Secondary	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.	Week 8, Week 14
Secondary	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).	Week 8
Secondary	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).	Week 8, Week 14
Secondary	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.	Week 8, Week 14
Secondary	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.	Week 8, Week 14
Secondary	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.	Week 8, Week 14
Secondary	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.	Baseline to Week 8
Secondary	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.	Baseline to Week 8
Secondary	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.	Week 8 to Week 14
Secondary	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.	Week 8 to Week 14
Secondary	Change From Baseline to Week 8 in Analog Scales- Firmness	mean change - scale of 0 (worst) to 10 (best).	baseline to Week 8
Secondary	Change From Baseline to Week 8 in Analog Scales- Maintenance	mean change - scale of 0 (worst) to 10 (best).	baseline to Week 8
Secondary	Change From Baseline to Week 8 in Analog Scales- Reliability	mean change - scale of 0 (worst) to 10 (best).	baseline to Week 8
Secondary	Change From Baseline to Week 8 in Analog Scales- General Sexual Performance	mean change - scale of 0 (worst) to 10 (best)	baseline to week 8
Secondary	Analog Scales- Firmness	mean - scale of 0 (worst) to 10 (best)	Week 8, Week 14
Secondary	Analog Scales- Maintenance	mean - scale of 0 (worst) to 10 (best)	Week 8, Week 14
Secondary	Analog Scales- Reliability	mean - scale of 0 (worst) to 10 (best)	Week 8, Week 14
Secondary	Analog Scales- General Sexual Performance	mean - scale of 0 (worst) to 10 (best)	Week 8, Week 14
Secondary	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.	Week 8 to Week 14
Secondary	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.	Week 8 to Week 14
Secondary	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.	Week 8 to Week 14
Secondary	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
Secondary	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 14
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.	Baseline to <Week 8 and Week 8 to <=Week 14

External Links

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