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

Phase 4

Completed

Conditions: Impotence

Registration Number: NCT00301262

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

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 183

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)	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

Name	Time	Method
Analog Scales- Maintenance	Week 8, Week 14	mean - scale of 0 (worst) to 10 (best)
Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score	Week 8	adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.
Patient Reported Erectile Function Assessment (PREFA) Total Score	Week 8, Week 14	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- Intercourse Satisfaction	Week 8	adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
International Index of Erectile Function (IIEF) Domain Scores- Erectile Function	Week 8, Week 14	Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction	Week 8, Week 14	Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score	Week 8	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).
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)	Week 8, 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)	Week 8 to Week 14	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)	Baseline to Week 8	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.
International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction	Week 8, Week 14	Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
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)	Week 8, 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.
International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire	Week 8, Week 14	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	Week 8	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.
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function	Week 8	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- Overall Satisfaction	Week 8	adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).
Erectile Distress Scale (EDS) Total Score	Week 8, Week 14	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 Week 8 in Analog Scales- Reliability	baseline to Week 8	mean change - scale of 0 (worst) to 10 (best).
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0	Baseline to <Week 8 and Week 8 to <=Week 14	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 3	Baseline to <Week 8 and Week 8 to <=Week 14	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.
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index	Week 8, Week 14	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 DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function	Week 8	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	Week 8	adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).
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)	Week 8, 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.
Change From Baseline to Week 8 in Analog Scales- Maintenance	baseline to Week 8	mean change - scale of 0 (worst) to 10 (best).
Change From Baseline to Week 8 in Analog Scales- General Sexual Performance	baseline to week 8	mean change - scale of 0 (worst) to 10 (best)
Analog Scales- Reliability	Week 8, Week 14	mean - scale of 0 (worst) to 10 (best)
Shift in Responder Rate From Week 8 to Week 14 for GEQ2	Week 8 to 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 to GEQ 2.
International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function	Week 8, Week 14	Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Quality of Erection Questionnaire (QEQ) Total Score	Week 8, Week 14	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).
Change From Baseline to Week 8 in Analog Scales- Firmness	baseline to Week 8	mean change - scale of 0 (worst) to 10 (best).
Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1	Week 8 to 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 to GEQ 1.
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1	Baseline to <= Week 14	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	Baseline to <Week 8 and Week 8 to <=Week 14	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 4	Baseline to <Week 8 and Week 8 to <=Week 14	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 Second Erections Grade 2	Baseline to <Week 8 and Week 8 to <=Week 14	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.
Percentage of Occasions of Ejaculation and/or Orgasm Event Log	Week 8 to Week 14	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.
Analog Scales- Firmness	Week 8, Week 14	mean - scale of 0 (worst) to 10 (best)
Analog Scales- General Sexual Performance	Week 8, Week 14	mean - scale of 0 (worst) to 10 (best)
Shift in Responder Rate From Week 8 to Week 14 for GEQ3	Week 8 to Week 14	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 3 or 4	Baseline to <Week 8 and Week 8 to <=Week 14	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 1	Baseline to <Week 8 and Week 8 to <=Week 14	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 0	Baseline to <Week 8 and Week 8 to <=Week 14	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 3	Baseline to <Week 8 and Week 8 to <=Week 14	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	Baseline to <Week 8 and Week 8 to <=Week 14	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	Baseline to <Week 8 and Week 8 to <=Week 14	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	Baseline to <Week 8 and Week 8 to <=Week 14	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.