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

PHASE4CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

December 31, 2002

Study Completion Date

January 31, 2004

Conditions
Erectile DysfunctionDiabetes Mellitus, Type 2
Interventions
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).

Trial Locations (29)

14209

Pfizer Investigational Site, Buffalo

21224

Pfizer Investigational Site, Baltimore

21287

Pfizer Investigational Site, Baltimore

35801

Pfizer Investigational Site, Huntsville

47150

Pfizer Investigational Site, New Albany

55416

Pfizer Investigational Site, Minneapolis

63104

Pfizer Investigational Site, St Louis

63117

Pfizer Investigational Site, Richmond Heights

66211

Pfizer Investigational Site, Overland Park

70112

Pfizer Investigational Site, New Orleans

78217

Pfizer Investigational Site, San Antonio

85006

Pfizer Investigational Site, Phoenix

90048

Pfizer Investigational Site, Los Angeles

90212

Pfizer Investigational Site, Beverly Hills

91010

Pfizer Investigational Site, Duarte

92037

Pfizer Investigational Site, La Jolla

92093

Pfizer Investigational Site, La Jolla

92161

Pfizer Investigational Site, San Diego

92653

Pfizer Investigational Site, Laguna Woods

97201

Pfizer Investigational Site, Portland

97504

Pfizer Investigational Site, Medford

98023

Pfizer Investigational Site, Tacoma

98034

Pfizer Investigational Site, Kirkland

98405

Pfizer Investigational Site, Tacoma

06850

Pfizer Investigational Site, Norwalk

06708

Pfizer Investigational Site, Waterbury

02215

Pfizer Investigational Site, Boston

78229-3894

Pfizer Investigational Site, San Antonio

T2N2T9

Pfizer Investigational Site, Calgary

All Listed Sponsors
lead

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

INDUSTRY

NCT00645268 - 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 | Biotech Hunter | Biotech Hunter