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”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• 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).

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Placebo Comparator: Arm 2
• Other: Open-Label Arm

Primary Measures

• The IIEF Erectile Function (EF) Domain score
  • Time Frame: Week 4
    Safety Issue?: No

Secondary Measures

• Intercourse success rate based on Event Logs
  • Time Frame: continuous
    Safety Issue?: No
• Ability to obtain an erection hard enough to attempt sexual intercourse post dose of sildenafil
  • Time Frame: continuous
    Safety Issue?: No
• 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
    Safety Issue?: No
• Responses to International Index of Erectile Function (IIEF) and secondary IIEF Domain scores (Orgasm; Desire; Intercourse Satisfaction; Overall Satisfaction)
  • Time Frame: Week 16
    Safety Issue?: No
• Reponses to the Global Efficacy Assessment Questions
  • Time Frame: Week 16
    Safety Issue?: No
• Flow mediated brachial artery dilation (FMD) as an index of generalized endothelial function
  • Time Frame: Week 4, 6, and 16
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00645268

Study ID Number: A1481146

ClinicalTrials.gov Identifier: NCT00645268

Health Authority: United States: Food and Drug Administration

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