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

Completed · Phase 4 · Has a placebo group

Conditions studied: Erectile Dysfunction, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00645268

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

300

Starts

2002-12-01

Expected to finish

2004-01-01

Last updated by the study team

2021-02-01

Who can join

Age: 35 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Huntsville, Alabama, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Beverly Hills, California, United States
• Pfizer Investigational Site — Duarte, California, United States
• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — Laguna Woods, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Norwalk, Connecticut, United States
• Pfizer Investigational Site — Waterbury, Connecticut, United States
• Pfizer Investigational Site — New Albany, Indiana, United States
• Pfizer Investigational Site — Overland Park, Kansas, United States
• Pfizer Investigational Site — New Orleans, Louisiana, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Minneapolis, Minnesota, United States
• Pfizer Investigational Site — Richmond Heights, Missouri, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — Buffalo, New York, United States
• Pfizer Investigational Site — Medford, Oregon, United States
• Pfizer Investigational Site — Portland, Oregon, United States
• Pfizer Investigational Site — San Antonio, Texas, United States
• Pfizer Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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