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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Endometriosis

Treatments: Drug: PF-02413873 100 mg QD; Drug: PF-02413873 1500 mg QD; Drug: PF-02413873 500 mg QD; Drug: PF-02413873 20 mg QD; Drug: PF-02413873 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00800618

B0461002

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

PF-02413873

Experimental group

Description:

PF-2413873 active treatment

Treatment:

Drug: PF-02413873 1500 mg QD

Drug: PF-02413873 100 mg QD

Drug: PF-02413873 20 mg QD

Drug: PF-02413873 500 mg QD

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: PF-02413873 Placebo