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PF-00446687

Phase 2

Erectile Dysfunction | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 8, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00862888Study to Investigate Effect of a New Drug (PF-00446687) in Males Suffering From Erectile DysfunctionPHASE2 COMPLETED 39Jul 1, 2007Feb 1, 2008Apr 8, 20093 Norway, United Kingdom
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Study Endpoints
Primary Endpoints
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 Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1; Study Period 1, 2, 3 or 4PLACEBO_COMPARATORCohort 1: Exploring two single doses of PF-00446687 200 mg as well as sildenafil 100mg and placebo (double dummy design)
Cohort 2; study periods 1, 2, 3 or 4PLACEBO_COMPARATORCohort 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
NameTypeDescription
PF-00446687DRUGSingle 200mg dose as an oral solution
PlaceboDRUGPlacebo for oral solution
SildenafilDRUGSingle oral dose 100 mg tablet
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Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersNo
Study Sites3

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...

Countries:NorwayUnited Kingdom
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