Study to Investigate Effect of a New Drug (PF-00446687) in Males Suffering From Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

A 2-Cohort, Multi-Centre, Randomised, Double Blind, Placebo Controlled 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses Of PF-00446687 On Erectile Function In Men Suffering From Erectile Dysfunction, Using 100 Mg Sildenafil As A Positive Control.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862888
• Other study ID #: A8361011
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2009
• Last updated: April 7, 2009
• Start date: July 2007
• Est. completion date: February 2008

Study information

• Verified date: April 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on erectile activity in males suffering from erectile dysfunction as well as examining the safety and toleration of the drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males aged 18-65 years who has given written informed consent to participate in the study and who suffers moderate to severe erectile dysfunction who has a current or recent successful response to treatment with phosphodiesterase type 5 inhibitors

Exclusion Criteria:

• Males with a history of significant cardiac disease; unstable angina or recent myocardial infarction.

• Males suffering from treated or untreated hypo- or hypertension

• Males currently receiving vasoactive medication

• Males taking medications contraindicated, or cautioned with sildenafil or MC4 agonists

Study Design

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• PF-00446687
Single 200mg dose as an oral solution
• Placebo
Placebo for oral solution
• Placebo
Placebo for tablet
• Sildenafil
Single oral dose 100 mg tablet
• PF-00446687
Single 125 mg dose as an oral solution
• PF-00446687
Single 175 mg dose as an oral solution
• PF-00446687
Single 20 mg dose as an oral solution
• Placebo
Placebo for oral solution
• Placebo
Placebo for tablet
• Sildenafil
Single oral dose 100 mg tablet

Locations

Country	Name	City	State
Norway	Pfizer Investigational Site	Oslo
United Kingdom	Pfizer Investigational Site	Belfast	Northern Ireland
United Kingdom	Pfizer Investigational Site	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess effect of single doses of PF-00446687 on erectile function (using the Rigiscan+ device)		Day of dosing	No
Primary	Evaluate subjective self-assessment of sexual interest and desire by means of a questionnaire		Day of dosing	No
Primary	Diary of sexual activities		From day of dosing to 7 days post-dose	No
Secondary	PK assessment of PF-00446687 ad sildenafil		Day of dosing	No
Secondary	Safety and toleration		Day of dosing to follow-up	No
Secondary	Assess variability of response and repeatability of design between 2 similar doses		Comparison of response to be assessed until 7 days post-dose	No
Secondary	Assess agouti related protein levels in this population		Day of dosing	No

External Links

•   To obtain contact information for a study center near you, click here.