A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses

Pfizer32 enrolled

Overview

The primary aim of this study is to assess how effective PF-00592379 is in restoring penile erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits where they will receive the following in random order; 2 separate doses of PF-00592379, sildenafil 100mg used as a positive control, or placebo (dummy medication). The effect on penile erections will be assessed in the clinic using penile plethysmography (RigiScan PlusTM technique).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Impotence

Interventions

PF-00592379DRUG

Sildenafil 100mgDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Erectile dysfunction, previous good response to an oral treatment for erectile dysfunction. Exclusion Criteria: * Patients with high blood pressure or certain heart conditions (e.g. angina, heart failure), regardless of whether treated or not. * Patients on nitrates or alpha-blocker medications.

Locations (2)

Pfizer Investigational Site

Oslo, Norway

Pfizer Investigational Site

Belfast, Northern Ireland, United Kingdom

Outcomes

Primary Outcomes

Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).

Secondary Outcomes

Duration and quality of penile erections recorded in a self-assessment diary.

Data from ClinicalTrials.gov

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