Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women

Wyeth is now a wholly owned subsidiary of Pfizer

Overview

The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated estrogens tablets produced using a new manufacturing process

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Menopause

Interventions

bazedoxifene/conjugated estrogensDRUG

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria * Healthy, postmenopausal women aged 35 to 70 years and weighing at least 50 kg (approx. 110 lbs). * At least 6 months of spontaneous amenorrhea (with follicle-stimulating hormone levels of 39 mIU/mL or greater). * Nonsmoker or smoker of fewer than 10 cigarettes per day, with ability to abstain for 5 days. Exclusion Criteria * Women with amenorrhea starting after 54 years of age. * A history or active presence of clinically important medical diseases. * Use of oral estrogen-, progestin, androgen-, or SERM-containing drug products within 30 days before receiving study drug.

Outcomes

Primary Outcomes

Pharmacokinetic measures of blood levels of endogenous estrogen hormones, conjugated estrogens and bazedoxifene.

Secondary Outcomes

Safety will be evaluated from reported signs and symptoms, scheduled physical examinations, gynecologic examinations, vital sign measurements, 12-lead ECG and clinical laboratory test results.

Data from ClinicalTrials.gov

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