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

Last updated date
Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35801, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction, Type 2 Diabetes Mellitus
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Erectile Dysfunction, Type 2 Diabetes MellitusA 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
  1. Huntsville, Alabama
  2. Phoenix, Arizona
  3. Beverly Hills, California
  4. Duarte, California
  5. La Jolla, California
  6. Laguna Woods, California
  7. LaJolla, California
  8. Los Angeles, California
  9. San Diego, California
  10. Norwalk, Connecticut
  11. Waterbury, Connecticut
  12. New Albany, Indiana
  13. Overland Park, Kansas
  14. New Orleans, Louisiana
  15. Baltimore, Maryland
  16. Baltimore, Maryland
  17. Boston, Massachusetts
  18. Minneapolis, Minnesota
  19. Richmond Heights, Missouri
  20. St. Louis, Missouri
  21. Buffalo, New York
  22. Medford, Oregon
  23. Portland, Oregon
  24. San Antonio, Texas
  25. San Antonio, Texas
  26. Kirkland, Washington
  27. Tacoma, Washington
  28. Tacoma, Washington
  29. Calgary,
Male
35 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Erectile Dysfunction
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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: 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.
  • 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).
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: sildenafil
  • Placebo Comparator: Arm 2
    Intervention: Drug: placebo
  • Open-Label Arm
    Intervention: Drug: sildenafil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 20, 2008)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00645268
Other Study ID Numbers  ICMJE A1481146
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP