Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen Forms

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

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-07-31

Brief Summary

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The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is given in combination with 2 different formulations of conjugated estrogens. It is an open label study with no placebo control or comparator drugs. Subjects will take one dose of the investigation formulation daily for 14 days.

Detailed Description

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Conditions

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Postmenopause

Keywords

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Postmenopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bazedoxifene/conjugated estrogens

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women, aged 40 to 65 years.
* Use of oral estrogen-, progestin-, or androgen-, or SERM-containing drug products within 8 weeks before screening.
* A history or active presence of clinically relevant important medical disease.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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3115A1-1121

Identifier Type: -

Identifier Source: org_study_id