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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00862888

Purpose

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.

Condition	Intervention	Phase
Erectile Dysfunction	Drug: PF-00446687 Drug: Placebo Drug: Sildenafil	Phase II

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Assess effect of single doses of PF-00446687 on erectile function (using the Rigiscan+ device) [ Time Frame: Day of dosing ] [ Designated as safety issue: No ]
Evaluate subjective self-assessment of sexual interest and desire by means of a questionnaire [ Time Frame: Day of dosing ] [ Designated as safety issue: No ]
Diary of sexual activities [ Time Frame: From day of dosing to 7 days post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PK assessment of PF-00446687 ad sildenafil [ Time Frame: Day of dosing ] [ Designated as safety issue: No ]
Safety and toleration [ Time Frame: Day of dosing to follow-up ] [ Designated as safety issue: No ]
Assess variability of response and repeatability of design between 2 similar doses [ Time Frame: Comparison of response to be assessed until 7 days post-dose ] [ Designated as safety issue: No ]
Assess agouti related protein levels in this population [ Time Frame: Day of dosing ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	July 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1; Study Period 1, 2, 3 or 4: Placebo Comparator Cohort 1: Exploring two single doses of PF-00446687 200 mg as well as sildenafil 100mg and placebo (double dummy design)	Drug: PF-00446687 Single 200mg dose as an oral solution Drug: Placebo Placebo for oral solution Drug: Placebo Placebo for tablet Drug: Sildenafil Single oral dose 100 mg tablet
Cohort 2; study periods 1, 2, 3 or 4: Placebo Comparator Cohort 2: Exploring single doses of PF-00446687 20 mg - 175 mg. Subjects to receive two of 3 possible doses of PF-00446687 as well as a single dose of sildenafil 100mg and placebo (double dummy design).	Drug: PF-00446687 Single 125 mg dose as an oral solution Drug: PF-00446687 Single 175 mg dose as an oral solution Drug: PF-00446687 Single 20 mg dose as an oral solution Drug: Placebo Placebo for oral solution Drug: Placebo Placebo for tablet Drug: Sildenafil Single oral dose 100 mg tablet

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862888

Locations

Norway
Pfizer Investigational Site
Oslo, Norway
United Kingdom, Northern Ireland
Pfizer Investigational Site
Belfast, Northern Ireland, United Kingdom, BT9 6AD
United Kingdom, West Yorkshire
Pfizer Investigational Site
Leeds, West Yorkshire, United Kingdom, LS2 9LH

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8361011
Study First Received:	March 16, 2009
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00862888 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Oxymetazoline
Vasodilator Agents
Phosphodiesterase Inhibitors
Sexual Dysfunction, Physiological
Phenylephrine

Mental Disorders
Sildenafil
Cardiovascular Agents
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Sildenafil
Enzyme Inhibitors
Cardiovascular Agents
Genital Diseases, Male

Sexual and Gender Disorders
Pharmacologic Actions
Sexual Dysfunction, Physiological
Phosphodiesterase Inhibitors
Mental Disorders
Therapeutic Uses
Erectile Dysfunction

ClinicalTrials.gov processed this record on May 07, 2009