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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00862888
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : April 8, 2009
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: PF-00446687 Drug: Placebo Drug: Sildenafil Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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.
Study Start Date : July 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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

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).
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

Drug: Placebo
Placebo for oral solution

Drug: Placebo
Placebo for tablet

Drug: Sildenafil
Single oral dose 100 mg tablet




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862888


Locations
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Norway
Pfizer Investigational Site
Oslo, Norway
United Kingdom
Pfizer Investigational Site
Belfast, Northern Ireland, United Kingdom, BT9 6AD
Pfizer Investigational Site
Leeds, West Yorkshire, United Kingdom, LS2 9LH
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00862888    
Other Study ID Numbers: A8361011
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: April 8, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents