CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 507 enrolled
Drug / intervention
BZA 20 mg/CE 0.45 mg +3 moredrug
Likely dose
BZA 20 mg/CE 0.45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT00774267N/ACompleted
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Evaluation Of Changes In Mammographic Breast Density Associated With Bazedoxifene Acetate/Conjugated Estrogens, Raloxifene And Placebo In Postmenopausal Women: An Ancillary Study Of Protocol 3115A1-303-WW

Pfizer·observational·Posted Oct 17, 2008·Updated Apr 8, 2014

In Brief

An observational study evaluating BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, and 2 other interventions for Osteoporosis. Completed, enrolled 507 participants across 26 sites in 4 countries.

Detailed Summary

The objective of the study is to evaluate quantitative changes in mammographic breast density from baseline to 24 months in postmenopausal women receiving daily doses of either BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, Raloxifene or placebo. The primary endpoint in this study is the change in mammographic breast density between baseline and month 24 for each group.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesBrazil, Netherlands, Norway, United States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2008
Enrollment StartJan 1, 2009
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.7 years ago

Interventions

BZA 20 mg/CE 0.45 mgdrug

There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.

BZA 20 mg/CE 0.625 mgdrug

There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.

Raloxifene 60 mgdrug

There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as raloxifene tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.

Placebodrug

There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as placebo capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.