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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00273416
First received: January 4, 2006
Last updated: August 23, 2006
Last verified: August 2006
  Purpose

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).


Condition Intervention Phase
Impotence
Drug: PF-00592379
Drug: Sildenafil 100mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • Duration and quality of penile erections recorded in a self-assessment diary.

Estimated Enrollment: 32
Study Start Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273416

Locations
Norway
Pfizer Investigational Site
Oslo, Norway, 0277
United Kingdom
Pfizer Investigational Site
Belfast, Northern Ireland, United Kingdom, BT9 6AD
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00273416     History of Changes
Other Study ID Numbers: A7771002
Study First Received: January 4, 2006
Last Updated: August 23, 2006
Health Authority: United Kingdom: Department of Health

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014