NCT00479778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

May 25, 2007

Last Update Submit

December 19, 2007

Conditions

Postmenopause

Keywords

Postmenopause

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic analyses.

Interventions

Bazedoxifene/conjugated estrogensDRUG

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Interventions

bazedoxifeneEstrogens, Conjugated (USP)

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 25, 2007

First Posted

May 28, 2007

Study Start

April 1, 2007

Study Completion

July 1, 2007

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

US(1)