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Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women

NCT ID: NCT00675688

Last Updated: 2008-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3544 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endometrial Hyperplasia Osteoporosis

Keywords

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

Bazedoxifene/Conjugate Estrogens (CE)

Intervention Type DRUG

B

Group Type ACTIVE_COMPARATOR

Raloxifene

Intervention Type DRUG

C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Bazedoxifene/Conjugate Estrogens (CE)

Intervention Type DRUG

Raloxifene

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Generally healthy, postmenopausal women aged 40 - 75 years inclusive
* Intact uterus
* Last natural menstrual cycle (without exogenous hormone therapy) completed at least 12 consecutive months before screening

Exclusion Criteria

* A history or active presence of thrombophlebitis, thrombosis or thromboembolic disorders
* A history or active presence of cerebrovascular accident, stroke, or transient ischemic attack
* A history or active presence of malignancy, or treatment for malignancy, within the previous 10 years

Additional criteria applies.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

References

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Archer DF, Freeman EW, Komm BS, Ryan KA, Yu CR, Mirkin S, Pinkerton JV. Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Vasomotor Symptoms in the Selective Estrogens, Menopause, and Response to Therapy Trials. J Womens Health (Larchmt). 2016 Nov;25(11):1102-1111. doi: 10.1089/jwh.2015.5558. Epub 2016 Sep 27.

Reference Type DERIVED
PMID: 27676118 (View on PubMed)

Lobo RA, Pinkerton JV, Gass MLS, Dorin MH, Ronkin S, Pickar JH, Constantine G. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. Fertil Steril. 2009 Sep;92(3):1025-1038. doi: 10.1016/j.fertnstert.2009.03.113. Epub 2009 Jul 26.

Reference Type DERIVED
PMID: 19635615 (View on PubMed)

Other Identifiers

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3115A1-303

Identifier Type: -

Identifier Source: org_study_id