NCT00242710

Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,083 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.

Conditions

• Endometrial Hyperplasia
• Osteoporosis

Interventions

Type	Name	Description
DRUG	Bazedoxifene/Conjugated Estrogen	Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
DRUG	Bazedoxifene/Conjugated Estrogen	Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
DRUG	CE 0.45 mg/MPA 1.5mg	Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
OTHER	Placebo	Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2005-10-20
• Last updated: 2013-12-20
• Results posted: 2013-12-20

Locations

9 sites across 1 country: United States