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

Condition(s) targeted: Impotence

Intervention: Viagra (Sildenafil citrate) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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: 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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Measure the impact of treatment with VIAGRA on the treatment satisfaction in ment with mild ED who are sexually dissatisfied, measured by ED Inventory of Treatment Satisfaction at the end of the double-blind treatment

Secondary outcome:

Measure Viagra's effect on the Patient Reported Erectile Function Assessment

measure Viagra's effect on the erectile function parameters

measure treatment's effect on degree of bother

examine correlation between degree of bother and International Index of Erectile Function & Quality of Life

report Viagra's safety in this patient population?????

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Pfizer Investigational Site, Calgary, Alberta T2L 1K8, Canada

Pfizer Investigational Site, Calgary, Alberta T2V 4R6, Canada

Pfizer Investigational Site, Edmonton, Alberta T5H 4B9, Canada

Pfizer Investigational Site, Victoria, British Columbia V8T 5G1, Canada

Pfizer Investigational Site, Vancouver, British Columbia V6Z 2T1, Canada

Pfizer Investigational Site, Surrey, British Columbia V3V 1N1, Canada

Pfizer Investigational Site, Langley, British Columbia V3A 4H9, Canada

Pfizer Investigational Site, Vancouver, British Columbia V5Z 1K3, Canada

Pfizer Investigational Site, Bay Roberts, Newfoundland and Labrador A0A 1G0, Canada

Pfizer Investigational Site, Halifax, Nova Scotia B3H 3A7, Canada

Pfizer Investigational Site, Toronto, Ontario M6A 3B5, Canada

Pfizer Investigational Site, London, Ontario N6A 4V2, Canada

Pfizer Investigational Site, Oakville, Ontario L6H 3P1, Canada

Pfizer Investigational Site, Kingston, Ontario K7L 3J7, Canada

Pfizer Investigational Site, Toronto, Ontario M5T 2S8, Canada

Pfizer Investigational Site, Corunna, Ontario N0N 1G0, Canada

Pfizer Investigational Site, Sarnia, Ontario N7T 4X3, Canada

Pfizer Investigational Site, Barrie, Ontario L4M 7G1, Canada

Pfizer Investigational Site, Montréal, Quebec H2X 1N8, Canada

Pfizer Investigational Site, Montreal, Quebec H2X 1N8, Canada

Pfizer Investigational Site, Montreal, Quebec H3S 1Z1, Canada

Pfizer Investigational Site, Montreal, Quebec H2L 5B1, Canada

Pfizer Investigational Site, Pointe-Claire, Quebec H9R 4S3, Canada

Pfizer Investigational Site, Chicoutimi, Quebec G7H 4A3, Canada

Pfizer Investigational Site, St. Leonard, Quebec H1S 3A9, Canada

Pfizer Investigational Site, Sherbrooke, Quebec J1H 1Z1, Canada

Pfizer Investigational Site, L'Ancienne-Lorette, Quebec G2E 2X1, Canada

To obtain contact information for a study center near you, click here.

Starting date: November 2005
Last updated: October 10, 2007