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Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

NCT00808132 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1886

Last updated 2014-04-08

Study results available
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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.

Conditions

Interventions

DRUG

bazedoxifene 20 mg/ conjugated estrogens 0.45 mg

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

DRUG

bazedoxifene 20 mg/ conjugated estrogens 0.625 mg

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

DRUG

bazedoxifene 20 mg

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

DRUG

conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States
  • Argentina
  • Australia
  • Chile
  • Colombia
  • Denmark
  • Finland
  • Hungary
  • Mexico
  • New Zealand
  • Norway
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00808132 on ClinicalTrials.gov