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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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction Diabetes Mellitus, Type 2 |
Drug: sildenafil Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
- The IIEF Erectile Function (EF) Domain score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
- Intercourse success rate based on Event Logs [ Time Frame: continuous ] [ Designated as safety issue: No ]
- Ability to obtain an erection hard enough to attempt sexual intercourse post dose of sildenafil [ Time Frame: continuous ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
- Reponses to the Global Efficacy Assessment Questions [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- Flow mediated brachial artery dilation (FMD) as an index of generalized endothelial function [ Time Frame: Week 4, 6, and 16 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | December 2002 |
| Study Completion Date: | January 2004 |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
| 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.
|
| Open-Label Arm |
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).
|
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | 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.
Contacts and Locations
Show 29 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00645268 History of Changes |
| Other Study ID Numbers: | A1481146 |
| Study First Received: | March 20, 2008 |
| Last Updated: | March 20, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Erectile Dysfunction Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders |
Mental Disorders Sildenafil Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013