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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00862888

Enrollment

Registered

2009-03-17

Start date

2007-07-31

Completion date

2008-02-29

Last updated

2009-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

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.

Interventions

DRUGPF-00446687

Single 200mg dose as an oral solution

DRUGPlacebo

Placebo for oral solution

DRUGSildenafil

Single oral dose 100 mg tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Measure	Time frame
PK assessment of PF-00446687 ad sildenafil	Day of dosing
Assess agouti related protein levels in this population	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

Countries

Norway, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026