A Study Of The Safety and Efficacy Of Viagra In Men With Erectile Dysfunction Who Do Not Self Identify.

Phase 4

Completed

• Conditions: Impotence
• Interventions: Drug: Viagra (sildenafil citrate); Drug: Placebo

• Registration Number: NCT00343200
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify as having ED.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-20
• Study First Submitted QC: 2006-06-20
• Study First Posted: 2006-06-22
• Study Start: 2006-07
• Study Completion: 2007-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 371

Inclusion Criteria

• Men who do not identify as having ED with documented ED
• Men 30 years of age and older
• At least one prespecified risk factor for ED

Exclusion Criteria

• Subjects currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis
• Subjects with a known history of retinitis pigmentosa.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sildenafil	Viagra (sildenafil citrate)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
To determine the change from baseline in Erectile Function (EF) domain of International Index of Erectile Function (IIEF).	Week 8

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	up to 12 Weeks
Other questionnaires and variables such as IIEF, SEAR, GEAQ, SEX-Q, QEQ, EDITS, SEP, Event Log, Erection Hardness Grading Score, and Morisky Compliance.	Weeks 8 and 12

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Oregon, Wisconsin, United States