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: December 8, 2008
Last verified: December 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Analog Scales- Maintenance [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 8 in Analog Scales- Reliability [ Time Frame: baseline to Week 8 ] [ Designated as safety issue: No ]
  • Analog Scales- Firmness [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Shift in Responder Rate From Week 8 to Week 14 for GEQ3 [ Time Frame: Week 8 to Week 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of Occasions of Successful Intercourse (Event Log) [ Time Frame: Week 8 to Week 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1 [ Time Frame: Week 8 to Week 14 ] [ Designated as safety issue: No ]
  • International Index of Erectile Function (IIEF) Domain Scores- Erectile Function [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Analog Scales- General Sexual Performance [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Percentage of Occasions of Successful Intercourse (Event Log) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of Occasions of Ejaculation and/or Orgasm (Event Log) [ Time Frame: Week 8 to Week 14 ] [ Designated as safety issue: No ]
  • Analog Scales- Reliability [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Erectile Distress Scale (EDS) Total Score [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Quality of Erection Questionnaire (QEQ) Total Score [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 8 in Analog Scales- Firmness [ Time Frame: baseline to Week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 8 in Analog Scales- General Sexual Performance [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]
  • Percentage of Occasions of Ejaculation and/or Orgasm (Event Log) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 8 in Analog Scales- Maintenance [ Time Frame: baseline to Week 8 ] [ Designated as safety issue: No ]
  • Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Shift in Responder Rate From Week 8 to Week 14 for GEQ2 [ Time Frame: Week 8 to Week 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Patient Reported Erectile Function Assessment (PREFA) Total Score [ Time Frame: Week 8, Week 14 ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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, V6Z 2T1
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 1K3
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, H3S 1Z1
Pfizer Investigational Site
Montreal, Quebec, Canada, H2X 1N8
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:
No publications provided

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: December 8, 2008
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual and Gender Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sildenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 21, 2014