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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2; Erectile Dysfunction
• Interventions: Drug: placebo; Drug: sildenafil

• Registration Number: NCT00645268
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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 available

Study Timeline

• Study Start: 2002-12
• Study Completion: 2004-01
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	placebo	-
Open-Label Arm	sildenafil	-
Arm 1	sildenafil	-

Primary Outcome Measures

Name	Time	Method
The IIEF Erectile Function (EF) Domain score	Week 4

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Calgary, Canada