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NCT00645268 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00645268
Other study ID # A1481146
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2002
Est. completion date January 2004

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date January 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 35 Years to 70 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• sildenafil
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.
• placebo
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.
• sildenafil
Eligible subjects then entered an open-label phase during which all subjects received sildenafil 50 mg as needed for sexual activity for the next 2 weeks, which could be titrated to either 25 mg or 100 mg based on the investigator's assessment of efficacy and tolerability, for 10 weeks (12 weeks total).

Locations
Country Name City State
Canada Pfizer Investigational Site Calgary
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Beverly Hills California
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Buffalo New York
United States Pfizer Investigational Site Duarte California
United States Pfizer Investigational Site Huntsville Alabama
United States Pfizer Investigational Site Kirkland Washington
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 Medford Oregon
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site New Albany Indiana
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Norwalk Connecticut
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Richmond Heights Missouri
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Tacoma Washington
United States Pfizer Investigational Site Tacoma Washington
United States Pfizer Investigational Site Waterbury Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary The IIEF Erectile Function (EF) Domain score Week 4
Secondary Intercourse success rate based on Event Logs continuous
Secondary Ability to obtain an erection hard enough to attempt sexual intercourse post dose of sildenafil continuous
Secondary Responses to the Self-Esteem And Relationship (SEAR) Questionnaire (including individual domain scores for the Sexual Activity, Self-Esteem And Relationship domains) Week 16
Secondary Responses to International Index of Erectile Function (IIEF) and secondary IIEF Domain scores (Orgasm; Desire; Intercourse Satisfaction; Overall Satisfaction) Week 16
Secondary Reponses to the Global Efficacy Assessment Questions Week 16
Secondary Flow mediated brachial artery dilation (FMD) as an index of generalized endothelial function Week 4, 6, and 16
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