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

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00479778

First received: May 25, 2007

Last updated: December 19, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

May 25, 2007

Last Updated Date

December 19, 2007

Start Date ^ICMJE

April 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Pharmacokinetic analyses.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00479778 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open Label, Randomized, Multicenter Study To Compare Bazedoxifene Steady-State Exposures Obtained With 2 Bazedoxifene Acetate/Conjugated Estrogen Formulations In Postmenopausal Women

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Postmenopause

Intervention ^ICMJE

Drug: Bazedoxifene/conjugated estrogens

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

40 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00479778

Other Study ID Numbers ^ICMJE

3115A1-1121

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

Information Provided By

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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