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NCT00273416 Clinical Trial

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

Impotence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00273416
Other study ID # A7771002
Secondary ID
Status Completed
Phase Phase 2
First received January 4, 2006
Last updated August 23, 2006
Start date January 2006

Study information
Verified date August 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Department of Health
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PF-00592379

• Sildenafil 100mg

Locations
Country Name City State
Norway Pfizer Investigational Site Oslo
United Kingdom Pfizer Investigational Site Belfast Northern Ireland

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Norway,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Duration of penile erections of greater than or equal to 60% rigidity as assessed by penile plethysmography (RigiScan PlusTM).
Secondary Duration and quality of penile erections recorded in a self-assessment diary.
See also
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Completed NCT00301262 - Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied Phase 4
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Completed NCT00547287 - Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations Phase 3
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Recruiting NCT00498680 - Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i Phase 4
Completed NCT00150358 - To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension . Phase 4
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