Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause

NCT ID: NCT00234819

Last Updated: 2007-12-28

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

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-02-28

Brief Summary

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The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.

Detailed Description

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Conditions

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Vasomotor Symptoms Associated With Menopause

Keywords

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Bazedoxifene/Conjugated Estrogen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago
* Intact uterus
* Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week

Exclusion Criteria

* History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders
* History of active presence of stroke, TIA, heart attack or ischemic heart disease
* History of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years
Minimum Eligible Age

40 Years

Maximum Eligible Age

64 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

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Phoenix, Arizona, United States

Site Status

Fort Myers, Florida, United States

Site Status

North Port Richey, Florida, United States

Site Status

Scarborough, Maine, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Pottstown, Pennsylvania, United States

Site Status

Countries

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United States

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)

Other Identifiers

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3115A1-305

Identifier Type: -

Identifier Source: org_study_id