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Study Evaluating Bazedoxifene...

Study Evaluating Bazedoxifene/CE in Postmenopausal Women

Last Updated: 2008-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Postmenopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bazedoxifene/Conjugated Estrogens

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes