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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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

NCT00645268•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

35 - 70 years

Sex

MALE

Healthy Volunteers

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.

Locations (29)

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

Key Dates

Start Date

December 1, 2002

Completion Date

January 1, 2004

Last Updated

February 1, 2021

Enrollment

300

ESTIMATED participants

Conditions

Erectile DysfunctionDiabetes Mellitus, Type 2

Interventions

sildenafil

DRUG

placebo

DRUG

sildenafil

DRUG

Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction

NCT07480161

Erectile Dysfunction With Diabetes Mellitus

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RECRUITINGPHASE2

TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men

NCT07460960

Erectile Dysfunction Due to Arterial DiseaseAtheroscleroses+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction

TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Safety Follow-up Study of Cellgram-ED in Post-Radical Prostatectomy Erectile Dysfunction

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED