Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose

Phase 4CompletedNCT00143260

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.250 enrolled

Overview

Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

250

Conditions

Impotence

Interventions

Viagra (Sildenafil Citrate) 100 mgDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men 18-70 years of age * Documented clinical diagnosis of erectile dysfunction of at least 3 months duration. Exclusion Criteria: * Subjects with penile implants * Subjects with a known history of retinitis pigmentosa. * Subjects, due to the requirement of 100 mg dosage, who are receiving concomitant treatment with the potent CYP3A4 inhibitor ritonavir.

Locations (25)

Pfizer Investigational Site

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra.

Secondary Outcomes

Proportion (as above) of patients at various endpoints. Other questionnaires such as SEP, IIEF.

Data from ClinicalTrials.gov

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