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

This study has been completed.

First Received on May 25, 2007. Last Updated on December 19, 2007 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00479778

Purpose

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.

Condition	Intervention	Phase
Postmenopause	Drug: Bazedoxifene/conjugated estrogens	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label, Randomized, Multicenter Study To Compare Bazedoxifene Steady-State Exposures Obtained With 2 Bazedoxifene Acetate/Conjugated Estrogen Formulations In Postmenopausal Women

Resource links provided by NLM:

Drug Information available for: Estrogens, conjugated Bazedoxifene

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

Pharmacokinetic analyses.

Estimated Enrollment:	72
Study Start Date:	April 2007
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479778

Locations

United States, Florida

Gainesville, Florida, United States, 32608

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00479778 History of Changes
Other Study ID Numbers:	3115A1-1121
Study First Received:	May 25, 2007
Last Updated:	December 19, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Postmenopause

Additional relevant MeSH terms:

Estrogens, Conjugated (USP)
Estrogens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012