ImpotencePhase 4NCT00301262
Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied
A Phase 4 study testing Viagra (Sildenafil citrate) in people with Impotence, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 26 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Impotence
- What is being tested?
- Viagra (Sildenafil citrate)
- How many people
- 183 participants
- Where
- 26 sitesCanada
- Study dates
- Nov 2005to Sep 2007
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men above age of majority
- Mild erectile dysfunction (IIEF-EF 22-25) and sexual dissatisfaction (IIEF-OS 7 or less)
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Canada26 sites
Pfizer Investigational Site
Barrie, Ontario, L4M 7G1
Pfizer Investigational Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0
Pfizer Investigational Site
Calgary, Alberta, T2L 1K8
Pfizer Investigational Site
Calgary, Alberta, T2V 4R6
Pfizer Investigational Site
Chicoutimi, Quebec, G7H 4A3
Pfizer Investigational Site
Corunna, Ontario, N0N 1G0
Pfizer Investigational Site
Edmonton, Alberta, T5H 4B9
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 3A7
Pfizer Investigational Site
Kingston, Ontario, K7L 3J7
Pfizer Investigational Site
L'Ancienne-Lorette, Quebec, G2E 2X1
Pfizer Investigational Site
Langley, British Columbia, V3A 4H9
Pfizer Investigational Site
London, Ontario, N6A 4V2
Pfizer Investigational Site
Montreal, Quebec, H2L 5B1
Pfizer Investigational Site
Montreal, Quebec, H2X 1N8
Pfizer Investigational Site
Montreal, Quebec, H3S 1Z1
Pfizer Investigational Site
Oakville, Ontario, L6H 3P1
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Pfizer Investigational Site
Saint-Léonard, Quebec, H1S 3A9
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 1Z1
Pfizer Investigational Site
Surrey, British Columbia, V3V 1N1
Pfizer Investigational Site
Toronto, Ontario, M5T 2S8
Pfizer Investigational Site
Toronto, Ontario, M6A 3B5
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 1K3
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 2T1
Pfizer Investigational Site
Victoria, British Columbia, V8T 5G1
About this study
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
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.
- Conditions
- Impotence
- Being tested
- Viagra (Sildenafil citrate)
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viagra (Sildenafil citrate)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 8
Secondary outcomes (48)
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).
Measured: 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.
Measured: Week 8
Patient Reported Erectile Function Assessment (PREFA) Total Score
PREFA Total Score: 8 = worst, 32 = best.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 8 to Week 14
Change From Baseline to Week 8 in Analog Scales- Firmness
mean change - scale of 0 (worst) to 10 (best).
Measured: baseline to Week 8
Change From Baseline to Week 8 in Analog Scales- Maintenance
mean change - scale of 0 (worst) to 10 (best).
Measured: baseline to Week 8
Change From Baseline to Week 8 in Analog Scales- Reliability
mean change - scale of 0 (worst) to 10 (best).
Measured: 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)
Measured: baseline to week 8
Analog Scales- Firmness
mean - scale of 0 (worst) to 10 (best)
Measured: Week 8, Week 14
Analog Scales- Maintenance
mean - scale of 0 (worst) to 10 (best)
Measured: Week 8, Week 14
Analog Scales- Reliability
mean - scale of 0 (worst) to 10 (best)
Measured: Week 8, Week 14
Analog Scales- General Sexual Performance
mean - scale of 0 (worst) to 10 (best)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to <Week 8 and Week 8 to <=Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startNov 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImpotenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301262
- Sponsor's protocol ID
- A1481238
- Status last verified
- Jan 2021
- First submitted
- 7 Mar 2006
- Last updated
- 1 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 28892218