NCT00862888

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
Last Updated

April 8, 2009

Status Verified

April 1, 2009

Enrollment Period

7 months

First QC Date

March 16, 2009

Last Update Submit

April 7, 2009

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • PK assessment of PF-00446687 ad sildenafil

    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

  • Assess agouti related protein levels in this population

    Day of dosing

Study Arms (2)

Cohort 1; Study Period 1, 2, 3 or 4

PLACEBO COMPARATOR

Cohort 1: Exploring two single doses of PF-00446687 200 mg as well as sildenafil 100mg and placebo (double dummy design)

Drug: PF-00446687Drug: PlaceboDrug: Sildenafil

Cohort 2; study periods 1, 2, 3 or 4

PLACEBO COMPARATOR

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-00446687Drug: PlaceboDrug: Sildenafil

Interventions

PF-00446687DRUG

Single 200mg dose as an oral solution

Cohort 1; Study Period 1, 2, 3 or 4
PlaceboDRUG

Placebo for oral solution

Cohort 1; Study Period 1, 2, 3 or 4
SildenafilDRUG

Single oral dose 100 mg tablet

Cohort 1; Study Period 1, 2, 3 or 4

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Oslo, Norway

Location

Pfizer Investigational Site

Belfast, Northern Ireland, BT9 6AD, United Kingdom

Location

Pfizer Investigational Site

Leeds, WEST Yorkshire, LS2 9LH, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

1-((1-tert-butyl-4-(2,4-difluorophenyl)pyrrolidin-3-yl)carbonyl)-3,5-dimethyl-4-phenylpiperidin-4-olSildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

July 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

April 8, 2009

Record last verified: 2009-04

Locations

GB(2)NO(1)