NCT00343200

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

A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Flexible-Dose Study To Assess The Efficacy And Safety Of Viagra (Sildenafil Citrate) In Men With Erectile Dysfunction (ED) Who Do Not Self Identify.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 371 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: Male
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Impotence

Interventions

Type	Name	Description
DRUG	Placebo	Placebo tablet orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 8 weeks (DB phase). In 4-week OL phase, subjects received sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period.
DRUG	Viagra (sildenafil citrate)	Sildenafil 50 mg or 100mg orally approximately 1 hour before sexual activity, with no more than 1 dose in a 24-hour period, for a total of 12 weeks (8-week DB phase and 4-week OL phase).

Timeline

• Start date: 2006-07-01
• Completion: 2007-09-01
• First posted: 2006-06-22
• Last updated: 2021-02-01

Locations

48 sites across 1 country: United States