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

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Oslo, , Norway
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00862888
Pfizer
Completed
Study to Investigate Effect of a New Drug (PF-00446687) in Males Suffering From Erectile Dysfunction

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Descriptive Information
Brief Title  ICMJE Study to Investigate Effect of a New Drug (PF-00446687) in Males Suffering From Erectile Dysfunction
Official Title  ICMJE 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.
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE
  • Drug: PF-00446687
    Single 200mg dose as an oral solution
  • Drug: Placebo
    Placebo for oral solution
  • Drug: Placebo
    Placebo for tablet
  • Drug: Sildenafil
    Single oral dose 100 mg tablet
  • Drug: PF-00446687
    Single 125 mg dose as an oral solution
  • Drug: PF-00446687
    Single 175 mg dose as an oral solution
  • Drug: PF-00446687
    Single 20 mg dose as an oral solution
Study Arms  ICMJE
  • Placebo Comparator: 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)
    Interventions:
    • Drug: PF-00446687
    • Drug: Placebo
    • Drug: Placebo
    • Drug: Sildenafil
  • Placebo Comparator: 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).
    Interventions:
    • Drug: PF-00446687
    • Drug: PF-00446687
    • Drug: PF-00446687
    • Drug: Placebo
    • Drug: Placebo
    • Drug: Sildenafil
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2009)
39
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion DateFebruary 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00862888
Other Study ID Numbers  ICMJE A8361011
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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