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PF-02413873

Phase 1

Endometriosis | Small molecule | Endocrine |Pfizer, Inc.|Trials Updated: Feb 10, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

PF-02413873 clinical trials

PF-02413873 · 1 trial · 1 indication

Phase 1 1
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 WomenEndometriosis
COMPLETED42 Analytics
PHASE1COMPLETED
A 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 Women
EndometriosisUnlock trial analytics

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 to 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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Frequently asked questions about PF-02413873

What is PF-02413873?

PF-02413873 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE) for endometriosis, a condition in which tissue similar to the uterine lining grows outside the uterus. It is in Phase 1 clinical development and has been studied in healthy young women. PF-02413873 is also referred to as PF-02413873 100 mg QD.

What is PF-02413873 used for in endometriosis?

PF-02413873 is being developed for endometriosis, an endocrine condition. The clinical program has evaluated its effects on sex hormone levels in healthy young women rather than in patients with confirmed endometriosis. It remains investigational and has not been approved for any use.

Who makes PF-02413873?

PF-02413873 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study of the compound conducted in the United States and Belgium.

What phase is PF-02413873 in?

PF-02413873 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. One Phase 1 trial has been completed, and no trials are currently active.

What clinical trials is PF-02413873 in?

PF-02413873 has been studied in one completed Phase 1 trial, NCT00800618, titled a study to investigate how the body handles multiple doses of PF-0243873 and the effect of PF-02413873 on sex hormone levels in healthy young women. It enrolled 42 participants, was randomized, double blind, and placebo controlled, and took place in the United States and Belgium.