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

January 4, 2006
August 23, 2006
January 2006
Not Provided
Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
Same as current
Complete list of historical versions of study NCT00273416 on ClinicalTrials.gov Archive Site
Duration and quality of penile erections recorded in a self-assessment diary.
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Impotence
  • Drug: PF-00592379
  • Drug: Sildenafil 100mg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Not Provided
Not Provided

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.
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway,   United Kingdom
 
NCT00273416
A7771002
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP