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Completed

NCT Number: NCT00862888

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

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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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Oslo, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-00446687

Drug

Single 200mg dose as an oral solution

Placebo

Drug

Placebo for oral solution

Sildenafil

Drug

Single oral dose 100 mg tablet

Primary outcomes

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

    Time frame: Day of dosing

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

    Time frame: Day of dosing

  3. Diary of sexual activities

    Time frame: From day of dosing to 7 days post-dose

Secondary outcomes

  1. PK assessment of PF-00446687 ad sildenafil

    Time frame: Day of dosing

  2. Safety and toleration

    Time frame: Day of dosing to follow-up

  3. 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

  4. Assess agouti related protein levels in this population

    Time frame: Day of dosing

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 17, 2009
Registry last updated
Apr 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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