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PF-02413873

Phase 1

Endometriosis | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 10, 2010

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00800618A Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young WomenPHASE1 COMPLETED 42Nov 1, 2008Jun 1, 2009Feb 10, 20104 United States, Belgium
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Study Endpoints
Primary Endpoints
Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests.
1 month
PF-02413873 pharmacokinetics
1 month
Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion.
14 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-02413873EXPERIMENTALPF-2413873 active treatment
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
PF-02413873 100 mg QDDRUG100 mg of PF-02413873 oral suspension once daily for 14 days
PF-02413873 1500 mg QDDRUG1500 mg of PF-02413873 oral suspension once daily for 14 days
PF-02413873 20 mg QDDRUG20 mg of PF-02413873 oral suspension once daily for 14 days
PF-02413873 500 mg QDDRUG500 mg of PF-02413873 oral suspension once daily for 14 days
PF-02413873 PlaceboDRUGPF-0241383 Placebo once daily for 14 days
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Eligibility Criteria
Age Range18 Years — 35 Years
SexFEMALE
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Healthy women of childbearing potential with a regular menstrual cycle Exclusion Criteria: * Evidence or history of any major disease * Pregnant or nursing women * Requirement for chronic medication

Countries:United StatesBelgium
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