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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Impotence

Intervention / Treatment
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* Drug: Viagra (Sildenafil citrate)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Viagra (Sildenafil citrate)|nan|

What is the study measuring?
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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 |