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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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)

Group Type PLACEBO_COMPARATOR

PF-00446687

Intervention Type DRUG

Single 200mg dose as an oral solution

Placebo

Intervention Type DRUG

Placebo for oral solution

Placebo

Intervention Type DRUG

Placebo for tablet

Sildenafil

Intervention Type DRUG

Single oral dose 100 mg tablet

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).

Group Type PLACEBO_COMPARATOR

PF-00446687

Intervention Type DRUG

Single 125 mg dose as an oral solution

PF-00446687

Intervention Type DRUG

Single 175 mg dose as an oral solution

PF-00446687

Intervention Type DRUG

Single 20 mg dose as an oral solution

Placebo

Intervention Type DRUG

Placebo for oral solution

Placebo

Intervention Type DRUG

Placebo for tablet

Sildenafil

Intervention Type DRUG

Single oral dose 100 mg tablet

Interventions

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PF-00446687

Single 200mg dose as an oral solution

Intervention Type DRUG

Placebo

Placebo for oral solution

Intervention Type DRUG

Placebo

Placebo for tablet

Intervention Type DRUG

Sildenafil

Single oral dose 100 mg tablet

Intervention Type DRUG

PF-00446687

Single 125 mg dose as an oral solution

Intervention Type DRUG

PF-00446687

Single 175 mg dose as an oral solution

Intervention Type DRUG

PF-00446687

Single 20 mg dose as an oral solution

Intervention Type DRUG

Placebo

Placebo for oral solution

Intervention Type DRUG

Placebo

Placebo for tablet

Intervention Type DRUG

Sildenafil

Single oral dose 100 mg tablet

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No