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NCT00675688

A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women

Completed Phase 3 Last updated 9 May 2008
What this trial tests

Phase 3 trial testing Bazedoxifene/Conjugate Estrogens (CE) in Endometrial Hyperplasia in 3,544 participants. Completed in 1 January 2006.

Timeline
1 April 2002
Primary endpoint
1 January 2006
1 January 2006

Quick facts

Lead sponsorWyeth is now a wholly owned subsidiary of Pfizer
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment3,544
Start date1 April 2002
Primary completion1 January 2006
Estimated completion1 January 2006

Drugs / interventions tested

Conditions studied

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer — full company profile →

Who can join

Adults 40 to 75, female only, with Endometrial Hyperplasia or Osteoporosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Vasomotor Symptoms in the Selective Estrogens, Menopause, and Response to Therapy Trials.
    Archer DF, Freeman EW, Komm BS, Ryan KA, et al · · 2016 · cited 5× · PMID 27676118 · DOI 10.1089/jwh.2015.5558
  2. Patient considerations in the management of menopausal symptoms: role of conjugated estrogens with bazedoxifene.
    Kagan R, Goldstein SR, Pickar JH, Komm BS. · · 2016 · cited 5× · PMID 27103814 · DOI 10.2147/tcrm.s63833

Verify or expand the search:

Other recruiting trials for Endometrial Hyperplasia

Currently open trials in the same condition.

Other Wyeth is now a wholly owned subsidiary of Pfizer trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00675688.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing