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

Viatris

Status and phase: Completed; Phase 4

Conditions: Impotence

Treatments: Drug: Viagra (sildenafil citrate); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00343200

A1481247

Details and patient eligibility

About

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.

Enrollment: 371 patients

Sex: Male

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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371 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Sildenafil

Experimental group

Treatment:

Drug: Viagra (sildenafil citrate)