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Trial record 2 of 3 for:    "Endometrial Hyperplasia" | "Bazedoxifene"

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

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ClinicalTrials.gov Identifier: NCT00675688
Recruitment Status : Completed
First Posted : May 12, 2008
Last Update Posted : May 12, 2008
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Endometrial Hyperplasia Osteoporosis Drug: Bazedoxifene/Conjugate Estrogens (CE) Drug: Raloxifene Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3544 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Study Start Date : April 2002
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Experimental: A Drug: Bazedoxifene/Conjugate Estrogens (CE)
Active Comparator: B Drug: Raloxifene
Placebo Comparator: C Drug: Placebo



Primary Outcome Measures :
  1. To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women. [ Time Frame: one year ]

Secondary Outcome Measures :
  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. [ Time Frame: one year ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675688


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00675688     History of Changes
Other Study ID Numbers: 3115A1-303
First Posted: May 12, 2008    Key Record Dates
Last Update Posted: May 12, 2008
Last Verified: May 2008

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Menopause

Additional relevant MeSH terms:
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Endometrial Hyperplasia
Bazedoxifene
Osteoporosis
Hyperplasia
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Estrogens
Estrogens, Conjugated (USP)
Raloxifene Hydrochloride
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents