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

Pfizer42 enrolled

Overview

The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873 has on sex hormones in healthy young women

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Endometriosis

Interventions

PF-02413873 100 mg QDDRUG

100 mg of PF-02413873 oral suspension once daily for 14 days

PF-02413873 1500 mg QDDRUG

1500 mg of PF-02413873 oral suspension once daily for 14 days

PF-02413873 20 mg QDDRUG

20 mg of PF-02413873 oral suspension once daily for 14 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Pfizer Investigational Site

New Haven, Connecticut, United States

Pfizer Investigational Site

Overland Park, Kansas, United States

Pfizer Investigational Site

Overland Park, Kansas, United States

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests.

Time frame: 1 month

PF-02413873 pharmacokinetics

Time frame: 1 month

Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion.

Time frame: 14 days

Data from ClinicalTrials.gov

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