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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country300 target enrollmentDecember 2002

ConditionsErectile Dysfunction Diabetes Mellitus, Type 2

Interventionssildenafil placebo

Drugssildenafil placebo

Overview

Phase: Phase 4
Intervention: sildenafil
Conditions: Erectile Dysfunction
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 300
Locations: 1
Primary Endpoint: The IIEF Erectile Function (EF) Domain score
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2002

End Date

January 2004

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Arm 1

Intervention: sildenafil

Arm 2

Intervention: placebo

Open-Label Arm

Intervention: sildenafil

Outcomes

Primary Outcomes

The IIEF Erectile Function (EF) Domain score

Time Frame: Week 4

Secondary Outcomes

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