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

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.

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: PF-00446687; Drug: Placebo; Drug: Placebo; Drug: Sildenafil; Drug: PF-00446687; Drug: PF-00446687; Drug: PF-00446687

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Cohort 1; Study Period 1, 2, 3 or 4; 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; 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
PLACEBO_COMPARATOR: Cohort 2; study periods 1, 2, 3 or 4; 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 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess effect of single doses of PF-00446687 on erectile function (using the Rigiscan+ device)	Day of dosing
Evaluate subjective self-assessment of sexual interest and desire by means of a questionnaire	Day of dosing
Diary of sexual activities	From day of dosing to 7 days post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
PK assessment of PF-00446687 ad sildenafil	Day of dosing
Safety and toleration	Day of dosing to follow-up
Assess variability of response and repeatability of design between 2 similar doses	Comparison of response to be assessed until 7 days post-dose
Assess agouti related protein levels in this population	Day of dosing

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (ACTUAL): February 1, 2008
• Study Completion (ACTUAL): February 1, 2008

Study Registration Dates

• First Submitted: March 16, 2009
• First Submitted That Met QC Criteria: March 16, 2009
• First Posted (ESTIMATE): March 17, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 8, 2009
• Last Update Submitted That Met QC Criteria: April 7, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: A8361011