Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women

Phase 1

Completed

• Conditions: Menopause

• Registration Number: NCT00396799
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated estrogens tablets produced using a new manufacturing process

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2006-11-07
• Study First Submitted QC: 2006-11-07
• Study First Posted: 2006-11-08
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-12
• Last Update Posted: 2007-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic measures of blood levels of endogenous estrogen hormones, conjugated estrogens and bazedoxifene.

Secondary Outcome Measures

Name	Time	Method
Safety will be evaluated from reported signs and symptoms, scheduled physical examinations, gynecologic examinations, vital sign measurements, 12-lead ECG and clinical laboratory test results.