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

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.

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Key information

Conditions

Postmenopause

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Gainesville, Florida, 32608, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bazedoxifene/conjugated estrogens

Drug

Primary outcomes

Pharmacokinetic analyses.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Study completion: 2007
First posted: May 28, 2007
Registry last updated: Dec 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed