Study Evaluating Bazedoxifene/CE in Postmenopausal Women

Wyeth is now a wholly owned subsidiary of Pfizer

Overview

The purpose of this clinical trial is to study the blood levels of a drug (conjugated estrogens) in the body from one dosage form compared to another. The four formulations of the study drug that eligible participants will receive will contain the same amounts of the same medications. In addition, information will also be obtained regarding the safety and tolerability of the formulations given to healthy postmenopausal women.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Postmenopause

Interventions

Bazedoxifene/Conjugated EstrogensDEVICE

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Postmenopausal women aged 35 to 70 years. * Spontaneous or surgical amenorrhea for at least 6 months. * Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg. Exclusion Criteria: * Hypertension or elevated supine blood pressure (\>139 mm Hg systolic or \>89 mm Hg diastolic). * History of any clinically important drug allergy. * Use of any prescription or investigational drug within 30 days before test article administration.

Outcomes

Primary Outcomes

The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE.

Data from ClinicalTrials.gov

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