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

January 28, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Calgary, Canada, T2N2T9
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pfizer Investigational Site
    • California
      • Beverly Hills, California, United States, 90212
        • Pfizer Investigational Site
      • Duarte, California, United States, 91010
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92093
        • Pfizer Investigational Site
      • Laguna Woods, California, United States, 92653
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90048
        • Pfizer Investigational Site
      • San Diego, California, United States, 92161
        • Pfizer Investigational Site
    • Connecticut
      • Norwalk, Connecticut, United States, 06850
        • Pfizer Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • Pfizer Investigational Site
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Pfizer Investigational Site
      • Baltimore, Maryland, United States, 21224
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Pfizer Investigational Site
    • Missouri
      • Richmond Heights, Missouri, United States, 63117
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63104
        • Pfizer Investigational Site
    • New York
      • Buffalo, New York, United States, 14209
        • Pfizer Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97201
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78217
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229-3894
        • Pfizer Investigational Site
    • Washington
      • Kirkland, Washington, United States, 98034
        • Pfizer Investigational Site
      • Tacoma, Washington, United States, 98405
        • Pfizer Investigational Site
      • Tacoma, Washington, United States, 98023
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm 2
Drug: 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.
Active Comparator: Arm 1
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.
Drug: 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).
Other: Open-Label Arm
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.
Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The IIEF Erectile Function (EF) Domain score
Time Frame: Week 4
Week 4

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1481146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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