NCT00675688

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,544

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2002

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2008

Completed
Last Updated

May 12, 2008

Status Verified

May 1, 2008

Enrollment Period

3.8 years

First QC Date

May 7, 2008

Last Update Submit

May 9, 2008

Conditions

Endometrial HyperplasiaOsteoporosis

Keywords

Menopause

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women.

    one year

Secondary Outcomes (1)

  • To evaluate the efficacy of Bazedoxifene/CE combinations in preventing osteoporosis. To evaluate the effects of Bazedoxifene/CE combinations on vaginal atrophy, metabolic parameters, uterine bleeding, vasomotor symptoms and quality of life indices.

    one year

Study Arms (3)

A

EXPERIMENTAL
Drug: Bazedoxifene/Conjugate Estrogens (CE)

B

ACTIVE COMPARATOR
Drug: Raloxifene

C

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Bazedoxifene/Conjugate Estrogens (CE)DRUG
A
RaloxifeneDRUG
B
PlaceboDRUG
C

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 27676118DERIVED

  • 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.

    PMID: 19635615DERIVED

MeSH Terms

Conditions

Endometrial HyperplasiaOsteoporosis

Interventions

bazedoxifeneRaloxifene Hydrochloride

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 12, 2008

Study Start

April 1, 2002

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

May 12, 2008

Record last verified: 2008-05