A Multicenter, Double-Blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Sildenafil on the As-Needed Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes

Condition(s) targeted: Erectile Dysfunction; Diabetes Mellitus, Type 2

Intervention: sildenafil (Drug); placebo (Drug); sildenafil (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

To determine the effect on erectile function in a population of type 2 diabetic men with erectile dysfunction who have undergone the following treatment regimen: pre-treatment with a daily dose of double-blind sildenafil versus placebo for 4 weeks (Phase I) followed by an as-needed, flexible-dose, open-label treatment phase with sildenafil for 12 weeks (Phase II). To assess safety and tolerability of this dosing regimen and to investigate its effects on endothelial function and subject's responses to the Self-Esteem And Relationship (SEAR) questionnaire.

Official title: A Multicenter, Double-Blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Viagra® (Sildenafil Citrate) on the PRN Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The IIEF Erectile Function (EF) Domain score

Secondary outcome:

Intercourse success rate based on Event Logs

Ability to obtain an erection hard enough to attempt sexual intercourse post dose of sildenafil

Responses to the Self-Esteem And Relationship (SEAR) Questionnaire (including individual domain scores for the Sexual Activity, Self-Esteem And Relationship domains)

Responses to International Index of Erectile Function (IIEF) and secondary IIEF Domain scores (Orgasm; Desire; Intercourse Satisfaction; Overall Satisfaction)

Reponses to the Global Efficacy Assessment Questions

Flow mediated brachial artery dilation (FMD) as an index of generalized endothelial function

Minimum age: 35 Years. Maximum age: 70 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

Patients had a documented clinical diagnosis of erectile dysfunction, a sexual partner for the duration of the study, and have a HbAlc of less than or equal to 10 at screening. Type 2 diabetic patients currently on insulin or on combination therapy with an oral hypoglycemic agent were not excluded.

Exclusion Criteria:

Excluded were subjects who had taken more than 6 doses of any PDE5 inhibitor and/or had taken their last dose less than 4 weeks prior to the screening visit; subjects with resting sitting and/or standing hypotension (BP < 90/50mmHg) or hypertension (BP > 170/110mmHg); and subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation in the last 3 months.

Pfizer Investigational Site, CALGARY T2N2T9, Canada

Pfizer Investigational Site, Huntsville, Alabama 35801, United States

Pfizer Investigational Site, Phoenix, Arizona 85006, United States

Pfizer Investigational Site, LaJolla, California 92037, United States

Pfizer Investigational Site, La Jolla, California 92093, United States

Pfizer Investigational Site, SAN DIEGO, California 92161, United States

Pfizer Investigational Site, Duarte, California 91010, United States

Pfizer Investigational Site, Beverly Hills, California 90212, United States

Pfizer Investigational Site, LOS ANGELES, California 90048, United States

Pfizer Investigational Site, LAGUNA WOODS, California 92653, United States

Pfizer Investigational Site, NORWALK, Connecticut 06850, United States

Pfizer Investigational Site, WATERBURY, Connecticut 06708, United States

Pfizer Investigational Site, New Albany, Indiana 47150, United States

Pfizer Investigational Site, Overland Park, Kansas 66211, United States

Pfizer Investigational Site, New Orleans, Louisiana 70112, United States

Pfizer Investigational Site, Baltimore, Maryland 21224, United States

Pfizer Investigational Site, Baltimore, Maryland 21287, United States

Pfizer Investigational Site, Boston, Massachusetts 02215, United States

Pfizer Investigational Site, MINNEAPOLIS, Minnesota 55416, United States

Pfizer Investigational Site, ST. LOUIS, Missouri 63104, United States

Pfizer Investigational Site, Richmond Heights, Missouri 63117, United States

Pfizer Investigational Site, Buffalo, New York 14209, United States

Pfizer Investigational Site, Portland, Oregon 97201, United States

Pfizer Investigational Site, MEDFORD, Oregon 97504, United States

Pfizer Investigational Site, SAN ANTONIO, Texas 78217, United States

Pfizer Investigational Site, San Antonio, Texas 78229-3894, United States

Pfizer Investigational Site, TACOMA, Washington 98023, United States

Pfizer Investigational Site, Tacoma, Washington 98405, United States

Pfizer Investigational Site, KIRKLAND, Washington 98034, United States

Pfizer Investigational Site, Kirkland, Washington 98034, United States

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

Starting date: December 2002
Ending date: January 2004
Last updated: March 20, 2008