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

A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses Of PF-00592379 On Erectile Function, Using 100mg Sildenafil As A Positive Control

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00273416

Enrollment

Registered

2006-01-09

Start date

2006-01-31

Completion date

Unknown

Last updated

2006-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impotence

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).

Interventions

DRUGPF-00592379

DRUGSildenafil 100mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Duration and quality of penile erections recorded in a self-assessment diary.	—

Countries

Norway, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026