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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00645268
Collaborator
(none)
300
29
3
13
10.3
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Dec 1, 2002
Actual Study Completion Date :
Jan 1, 2004

Arms and Interventions

Arm Intervention/Treatment
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.

Other: 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).

Outcome Measures

Primary Outcome Measures

  1. The IIEF Erectile Function (EF) Domain score [Week 4]

Secondary Outcome Measures

  1. Intercourse success rate based on Event Logs [continuous]

  2. Ability to obtain an erection hard enough to attempt sexual intercourse post dose of sildenafil [continuous]

  3. Responses to the Self-Esteem And Relationship (SEAR) Questionnaire (including individual domain scores for the Sexual Activity, Self-Esteem And Relationship domains) [Week 16]

  4. Responses to International Index of Erectile Function (IIEF) and secondary IIEF Domain scores (Orgasm; Desire; Intercourse Satisfaction; Overall Satisfaction) [Week 16]

  5. Reponses to the Global Efficacy Assessment Questions [Week 16]

  6. Flow mediated brachial artery dilation (FMD) as an index of generalized endothelial function [Week 4, 6, and 16]

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 70 Years
Sexes 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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Huntsville Alabama United States 35801
2 Pfizer Investigational Site Phoenix Arizona United States 85006
3 Pfizer Investigational Site Beverly Hills California United States 90212
4 Pfizer Investigational Site Duarte California United States 91010
5 Pfizer Investigational Site La Jolla California United States 92037
6 Pfizer Investigational Site La Jolla California United States 92093
7 Pfizer Investigational Site Laguna Woods California United States 92653
8 Pfizer Investigational Site Los Angeles California United States 90048
9 Pfizer Investigational Site San Diego California United States 92161
10 Pfizer Investigational Site Norwalk Connecticut United States 06850
11 Pfizer Investigational Site Waterbury Connecticut United States 06708
12 Pfizer Investigational Site New Albany Indiana United States 47150
13 Pfizer Investigational Site Overland Park Kansas United States 66211
14 Pfizer Investigational Site New Orleans Louisiana United States 70112
15 Pfizer Investigational Site Baltimore Maryland United States 21224
16 Pfizer Investigational Site Baltimore Maryland United States 21287
17 Pfizer Investigational Site Boston Massachusetts United States 02215
18 Pfizer Investigational Site Minneapolis Minnesota United States 55416
19 Pfizer Investigational Site Richmond Heights Missouri United States 63117
20 Pfizer Investigational Site Saint Louis Missouri United States 63104
21 Pfizer Investigational Site Buffalo New York United States 14209
22 Pfizer Investigational Site Medford Oregon United States 97504
23 Pfizer Investigational Site Portland Oregon United States 97201
24 Pfizer Investigational Site San Antonio Texas United States 78217
25 Pfizer Investigational Site San Antonio Texas United States 78229-3894
26 Pfizer Investigational Site Kirkland Washington United States 98034
27 Pfizer Investigational Site Tacoma Washington United States 98023
28 Pfizer Investigational Site Tacoma Washington United States 98405
29 Pfizer Investigational Site Calgary Canada T2N2T9

Sponsors and Collaborators

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

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00645268
Other Study ID Numbers:
  • A1481146
First Posted:
Mar 27, 2008
Last Update Posted:
Feb 1, 2021
Last Verified:
Jan 1, 2021

Study Results

No Results Posted as of Feb 1, 2021