Erectile dysfunction - Clinical trial details 

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

Recruitment status:
Not recruiting
Primary Sponsor:
Pfizer
Recruitment countries:
Norway,  United Kingdom
Health condition studied:
Erectile Dysfunction
URL:
Link to the clinical trial website

About the trial

Interventions:
Drug: PF-00446687
Drug: Placebo
Drug: Sildenafil
Key inclusion and exclusion 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
  • Age minimum:  18 Years
  • Age maximum:  65 Years
  • Gender:  Male
Primary outcomes:
Assess effect of single doses of PF-00446687 on erectile function (using the Rigiscan+ device)
Diary of sexual activities
Evaluate subjective self-assessment of sexual interest and desire by means of a questionnaire
Secondary outcomes:
Assess agouti related protein levels in this population
Assess variability of response and repeatability of design between 2 similar doses
PK assessment of PF-00446687 ad sildenafil
Safety and toleration
Target sample size:
39
Study type:
Interventional
Study design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Contacts:
  • Name:   Pfizer CT.gov Call Center
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  Pfizer

Technical details

Scientific 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.
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Main ID:
NCT00862888
Secondary ID:
A8361011
Register:
ClinicalTrials.gov
Date of registration:
16/03/2009
Date of first enrollment:
July 2007
Last refreshed:
17 October 2012

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