Study Evaluating Bazedoxifene/CE in Postmenopausal Women

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00550433

Collaborator

(none)

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this clinical trial is to study the blood levels of a drug (conjugated estrogens) in the body from one dosage form compared to another. The four formulations of the study drug that eligible participants will receive will contain the same amounts of the same medications. In addition, information will also be obtained regarding the safety and tolerability of the formulations given to healthy postmenopausal women.

Condition or Disease	Intervention/Treatment	Phase
Postmenopause	Device: Bazedoxifene/Conjugated Estrogens	Phase 1

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Clinical and Commercial Formulations of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women

Study Start Date :

Sep 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Postmenopausal women aged 35 to 70 years.
Spontaneous or surgical amenorrhea for at least 6 months.
Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg.

Exclusion Criteria:

Hypertension or elevated supine blood pressure (>139 mm Hg systolic or >89 mm Hg diastolic).
History of any clinically important drug allergy.
Use of any prescription or investigational drug within 30 days before test article administration.

Contacts and Locations

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00550433

Other Study ID Numbers:

3115A1-1117

First Posted:

Oct 29, 2007

Last Update Posted:

Jan 16, 2008

Last Verified:

Jan 1, 2008

Additional relevant MeSH terms:

Bazedoxifene

Estrogens

Estrogens, Conjugated (USP)

Study Results

No Results Posted as of Jan 16, 2008