Back to resultsA Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses
Primary Purpose
Impotence
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-00592379
Sildenafil 100mg
Sponsored by
About this trial
This is an interventional treatment trial for Impotence
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00273416
Brief Title
A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impotence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
32 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PF-00592379
Intervention Type
Drug
Intervention Name(s)
Sildenafil 100mg
Primary Outcome Measure Information:
Title
Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
Secondary Outcome Measure Information:
Title
Duration and quality of penile erections recorded in a self-assessment diary.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Oslo
ZIP/Postal Code
0277
Country
Norway
Facility Name
Pfizer Investigational Site
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 6AD
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7771002&StudyName=A+Randomized+Double+Blind%2C+Placebo+Controlled+Balanced+4%2DWay+Crossover+Study+To+Assess+The+Efficacy+Of+Single+Oral+Doses
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses
We'll reach out to this number within 24 hrs