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

NCT00645268 | Completed Phase 4

• 1 other identifier: A1481146
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 29

Brief 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.

Conditions

Erectile Dysfunction; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• The IIEF Erectile Function (EF) Domain score

  Week 4

Secondary Outcomes (6)

• Intercourse success rate based on Event Logs

  continuous

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

  continuous

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

  Week 16

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

  Week 16

• Reponses to the Global Efficacy Assessment Questions

  Week 16

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

Drug: sildenafil

Arm 2

PLACEBO COMPARATOR

Drug: placebo

Open-Label Arm

OTHER

Drug: sildenafil

Interventions

sildenafil DRUG

In the double-blind phase, patients received sildenafil 50 mg once daily during Week 1 (7 doses), followed by a daily dose of sildenafil 100 mg during the next 3 weeks.

Arm 1

placebo DRUG

In the double-blind phase, patients received placebo once daily during Week 1 (7 doses), followed by a daily dose of placebo during the next 3 weeks.

Arm 2

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

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

Study Sites (29)

Pfizer Investigational Site

Huntsville, Alabama, 35801, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85006, United States

Location

Pfizer Investigational Site

Beverly Hills, California, 90212, United States

Location

Pfizer Investigational Site

Duarte, California, 91010, United States

Location

Pfizer Investigational Site

La Jolla, California, 92037, United States

Location

Pfizer Investigational Site

La Jolla, California, 92093, United States

Location

Pfizer Investigational Site

Laguna Woods, California, 92653, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90048, United States

Location

Pfizer Investigational Site

San Diego, California, 92161, United States

Location

Pfizer Investigational Site

Norwalk, Connecticut, 06850, United States

Location

Pfizer Investigational Site

Waterbury, Connecticut, 06708, United States

Location

Pfizer Investigational Site

New Albany, Indiana, 47150, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66211, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70112, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21224, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21287, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Pfizer Investigational Site

Minneapolis, Minnesota, 55416, United States

Location

Pfizer Investigational Site

Richmond Heights, Missouri, 63117, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63104, United States

Location

Pfizer Investigational Site

Buffalo, New York, 14209, United States

Location

Pfizer Investigational Site

Medford, Oregon, 97504, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97201, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78217, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229-3894, United States

Location

Pfizer Investigational Site

Kirkland, Washington, 98034, United States

Location

Pfizer Investigational Site

Tacoma, Washington, 98023, United States

Location

Pfizer Investigational Site

Tacoma, Washington, 98405, United States

Location

Pfizer Investigational Site

Calgary, T2N2T9, Canada

Location

Related Links

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

MeSH Terms

Conditions

Erectile Dysfunction; Diabetes Mellitus, Type 2

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2008
• First Posted: March 27, 2008
• Study Start: December 1, 2002
• Study Completion: January 1, 2004
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

US (28); CA (1)