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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00301262
First received: March 7, 2006
Last updated: March 7, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Impotence Drug: Viagra (Sildenafil citrate) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8) [ Time Frame: 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:
  • Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index [ Time Frame: 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 Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score [ Time Frame: Week 8 ]
    adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.

  • Patient Reported Erectile Function Assessment (PREFA) Total Score [ Time Frame: 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- Erectile Function [ Time Frame: 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- Orgasmic Function [ Time Frame: 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 [ Time Frame: Week 8 ]
    adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).

  • Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction [ Time Frame: Week 8 ]
    adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).

  • Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction [ Time Frame: Week 8 ]
    adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).

  • International Index of Erectile Function (IIEF) Domain Scores- Erectile Function [ Time Frame: 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- Orgasmic Function [ Time Frame: Week 8, Week 14 ]
    Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).

  • International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire [ Time Frame: Week 8, Week 14 ]
    Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).

  • International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction [ Time Frame: Week 8, Week 14 ]
    Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).

  • International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction [ Time Frame: 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 [ Time Frame: 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.

  • Erectile Distress Scale (EDS) Total Score [ Time Frame: 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 End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score [ Time Frame: 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).

  • Quality of Erection Questionnaire (QEQ) Total Score [ Time Frame: 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).

  • 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) [ Time Frame: 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.

  • 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) [ Time Frame: 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.

  • 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) [ Time Frame: 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) [ Time Frame: 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.

  • Percentage of Occasions of Ejaculation and/or Orgasm (Event Log) [ Time Frame: 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.

  • Percentage of Occasions of Successful Intercourse (Event Log) [ Time Frame: 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 [ Time Frame: 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.

  • Change From Baseline to Week 8 in Analog Scales- Firmness [ Time Frame: baseline to Week 8 ]
    mean change - scale of 0 (worst) to 10 (best).

  • Change From Baseline to Week 8 in Analog Scales- Maintenance [ Time Frame: baseline to Week 8 ]
    mean change - scale of 0 (worst) to 10 (best).

  • Change From Baseline to Week 8 in Analog Scales- Reliability [ Time Frame: 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 [ Time Frame: baseline to week 8 ]
    mean change - scale of 0 (worst) to 10 (best)

  • Analog Scales- Firmness [ Time Frame: Week 8, Week 14 ]
    mean - scale of 0 (worst) to 10 (best)

  • Analog Scales- Maintenance [ Time Frame: Week 8, Week 14 ]
    mean - scale of 0 (worst) to 10 (best)

  • Analog Scales- Reliability [ Time Frame: Week 8, Week 14 ]
    mean - scale of 0 (worst) to 10 (best)

  • Analog Scales- General Sexual Performance [ Time Frame: Week 8, Week 14 ]
    mean - scale of 0 (worst) to 10 (best)

  • Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1 [ Time Frame: 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.

  • Shift in Responder Rate From Week 8 to Week 14 for GEQ2 [ Time Frame: 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.

  • Shift in Responder Rate From Week 8 to Week 14 for GEQ3 [ Time Frame: 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 0 [ Time Frame: 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 1 [ Time Frame: 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 [ Time Frame: 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 3 [ Time Frame: 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.

  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4 [ Time Frame: 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 First Erections Grade 3 or 4 [ Time Frame: 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 0 [ Time Frame: 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 1 [ Time Frame: 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 2 [ Time Frame: 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.

  • Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 183
Study Start Date: November 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301262

Locations
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2L 1K8
Pfizer Investigational Site
Calgary, Alberta, Canada, T2V 4R6
Pfizer Investigational Site
Edmonton, Alberta, Canada, T5H 4B9
Canada, British Columbia
Pfizer Investigational Site
Langley, British Columbia, Canada, V3A 4H9
Pfizer Investigational Site
Surrey, British Columbia, Canada, V3V 1N1
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 1K3
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V6Z 2T1
Pfizer Investigational Site
Victoria, British Columbia, Canada, V8T 5G1
Canada, Newfoundland and Labrador
Pfizer Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Pfizer Investigational Site
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, M5T 2S8
Pfizer Investigational Site
Toronto, Ontario, Canada, M6A 3B5
Canada, Quebec
Pfizer Investigational Site
Chicoutimi, Quebec, Canada, G7H 4A3
Pfizer Investigational Site
L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
Pfizer Investigational Site
Montreal, Quebec, Canada, H2L 5B1
Pfizer Investigational Site
Montreal, Quebec, Canada, H2X 1N8
Pfizer Investigational Site
Montreal, Quebec, Canada, H3S 1Z1
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00301262     History of Changes
Other Study ID Numbers: A1481238
Study First Received: March 7, 2006
Results First Received: November 12, 2008
Last Updated: March 7, 2017

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on July 26, 2017