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

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 Overview

• Status: Completed
• Conditions: Impotence
• Intervention / Treatment: Drug: Viagra (Sildenafil citrate)

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2L 1K8
      • Pfizer Investigational Site
    • Calgary, Alberta, Canada, T2V 4R6
      • Pfizer Investigational Site
    • Edmonton, Alberta, Canada, T5H 4B9
      • Pfizer Investigational Site
  • British Columbia
    • Langley, British Columbia, Canada, V3A 4H9
      • Pfizer Investigational Site
    • Surrey, British Columbia, Canada, V3V 1N1
      • Pfizer Investigational Site
    • Vancouver, British Columbia, Canada, V6Z 2T1
      • Pfizer Investigational Site
    • Vancouver, British Columbia, Canada, V5Z 1K3
      • Pfizer Investigational Site
    • Victoria, British Columbia, Canada, V8T 5G1
      • Pfizer Investigational Site
  • Newfoundland and Labrador
    • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
      • Pfizer Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Pfizer Investigational Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Pfizer Investigational Site
    • Corunna, Ontario, Canada, N0N 1G0
      • Pfizer Investigational Site
    • Kingston, Ontario, Canada, K7L 3J7
      • Pfizer Investigational Site
    • London, Ontario, Canada, N6A 4V2
      • Pfizer Investigational Site
    • Oakville, Ontario, Canada, L6H 3P1
      • Pfizer Investigational Site
    • Sarnia, Ontario, Canada, N7T 4X3
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M6A 3B5
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M5T 2S8
      • Pfizer Investigational Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 4A3
      • Pfizer Investigational Site
    • L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H2X 1N8
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H3S 1Z1
      • Pfizer Investigational Site
    • Montreal, Quebec, Canada, H2L 5B1
      • Pfizer Investigational Site
    • Montréal, Quebec, Canada, H2X 1N8
      • Pfizer Investigational Site
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Pfizer Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Pfizer Investigational Site
    • St. Leonard, Quebec, Canada, H1S 3A9
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Patient Reported Erectile Function Assessment (PREFA) Total Score	PREFA Total Score: 8 = worst, 32 = best.	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).	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).	Week 8
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Change From Baseline to Week 8 in Analog Scales- Firmness	mean change - scale of 0 (worst) to 10 (best).	baseline to Week 8
Change From Baseline to Week 8 in Analog Scales- Maintenance	mean change - scale of 0 (worst) to 10 (best).	baseline to Week 8
Change From Baseline to Week 8 in Analog Scales- Reliability	mean change - scale of 0 (worst) to 10 (best).	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)	baseline to week 8
Analog Scales- Firmness	mean - scale of 0 (worst) to 10 (best)	Week 8, Week 14
Analog Scales- Maintenance	mean - scale of 0 (worst) to 10 (best)	Week 8, Week 14
Analog Scales- Reliability	mean - scale of 0 (worst) to 10 (best)	Week 8, Week 14
Analog Scales- General Sexual Performance	mean - scale of 0 (worst) to 10 (best)	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline to <Week 8 and Week 8 to <=Week 14

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: March 7, 2006
• First Submitted That Met QC Criteria: March 9, 2006
• First Posted (Estimate): March 10, 2006

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: A1481238