CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,886 enrolled
Drug / intervention
bazedoxifene 20 mg/ conjugated estrogens 0.45 mg +4 moredrug
Likely dose
bazedoxifene 20 mg/ conjugated estrogens 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.

Search/NCT00808132
NCT00808132Phase 3Completed
CompareCT.gov

A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women

Pfizer·interventional·Posted Dec 15, 2008·Updated Apr 8, 2014

In Brief

A Phase 3 clinical trial evaluating bazedoxifene 20 mg/ conjugated estrogens 0.45 mg, bazedoxifene 20 mg/ conjugated estrogens 0.625 mg, and 3 other interventions for Menopause and Osteoporosis. Completed, enrolled 1,886 participants across 178 sites in 12 countries.

Detailed Summary

The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause, Osteoporosis
CountriesArgentina, Australia, Chile, Colombia, Denmark, Finland, Hungary, Mexico, New Zealand, Norway, Poland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2008
Enrollment StartJan 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.5 years ago

Interventions

bazedoxifene 20 mg/ conjugated estrogens 0.45 mgdrug

One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.

bazedoxifene 20 mg/ conjugated estrogens 0.625 mgdrug

One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.

bazedoxifene 20 mgdrug

One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.

conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mgdrug

One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year.

Placebodrug

One capsule, placebo (over-encapsulated), once a day for one year.