Back to results

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

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

PF-00446687

Placebo

Sildenafil

PF-00446687

Placebo

Sildenafil

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Arm Label

Cohort 1; Study Period 1, 2, 3 or 4

Cohort 2; study periods 1, 2, 3 or 4

Arm Description

Cohort 1: Exploring two single doses of PF-00446687 200 mg as well as sildenafil 100mg and placebo (double dummy design)

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).

Outcomes

Primary Outcome Measures

Assess effect of single doses of PF-00446687 on erectile function (using the Rigiscan+ device)

Evaluate subjective self-assessment of sexual interest and desire by means of a questionnaire

Diary of sexual activities

Secondary Outcome Measures

PK assessment of PF-00446687 ad sildenafil

Safety and toleration

Assess variability of response and repeatability of design between 2 similar doses

Assess agouti related protein levels in this population

Full Information

NCT ID

NCT00862888

First Posted

March 16, 2009

Last Updated

April 7, 2009

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00862888

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1; Study Period 1, 2, 3 or 4

Arm Type

Placebo Comparator

Arm Description

Cohort 1: Exploring two single doses of PF-00446687 200 mg as well as sildenafil 100mg and placebo (double dummy design)

Arm Title

Cohort 2; study periods 1, 2, 3 or 4

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

PF-00446687

Intervention Description

Single 200mg dose as an oral solution

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo for oral solution

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo for tablet

Intervention Type

Drug

Intervention Name(s)

Sildenafil

Intervention Description

Single oral dose 100 mg tablet

Intervention Type

Drug

Intervention Name(s)

PF-00446687

Intervention Description

Single 125 mg dose as an oral solution

Intervention Type

Drug

Intervention Name(s)

PF-00446687

Intervention Description

Single 175 mg dose as an oral solution

Intervention Type

Drug

Intervention Name(s)

PF-00446687

Intervention Description

Single 20 mg dose as an oral solution

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo for oral solution

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo for tablet

Intervention Type

Drug

Intervention Name(s)

Sildenafil

Intervention Description

Single oral dose 100 mg tablet

Primary Outcome Measure Information:

Title

Assess effect of single doses of PF-00446687 on erectile function (using the Rigiscan+ device)

Time Frame

Day of dosing

Title

Evaluate subjective self-assessment of sexual interest and desire by means of a questionnaire

Time Frame

Day of dosing

Title

Diary of sexual activities

Time Frame

From day of dosing to 7 days post-dose

Secondary Outcome Measure Information:

Title

PK assessment of PF-00446687 ad sildenafil

Time Frame

Day of dosing

Title

Safety and toleration

Time Frame

Day of dosing to follow-up

Title

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

Title

Assess agouti related protein levels in this population

Time Frame

Day of dosing

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

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

Country

Norway

Facility Name

Pfizer Investigational Site

City

Belfast

State/Province

Northern Ireland

ZIP/Postal Code

BT9 6AD

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS2 9LH

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8361011&StudyName=Study%20to%20investigate%20effect%20of%20a%20new%20drug%20%28PF-00446687%29%20in%20males%20suffering%20from%20erectile%20dysfunction

Description

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs