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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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35801 United States
Contact
1-800-718-1021
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 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.

NCT00645268
Pfizer
Completed
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

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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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Erectile Dysfunction
  • Diabetes Mellitus, Type 2
  • 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).
  • Active Comparator: Arm 1
    Intervention: Drug: sildenafil
  • Placebo Comparator: Arm 2
    Intervention: Drug: placebo
  • Open-Label Arm
    Intervention: Drug: sildenafil
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
January 2004
Not Provided

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.

Sexes Eligible for Study: Male
35 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00645268
A1481146
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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