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

Phase 2

Completed

• Conditions: Impotence

• Registration Number: NCT00273416
• Lead Sponsor: Pfizer

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-04
• Study First Submitted QC: 2006-01-04
• Study First Posted: 2006-01-09
• Status Verified: 2006-08
• Last Update Submitted: 2006-08-23
• Last Update Posted: 2006-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Belfast, Northern Ireland, United Kingdom