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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00479778

Enrollment

Registered

2007-05-28

Start date

2007-04-30

Completion date

2007-07-31

Last updated

2007-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopause

Keywords

Postmenopause

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.

Interventions

DRUGBazedoxifene/conjugated estrogens

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic analyses.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026