Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00675688

Purpose

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	Intervention	Phase
Endometrial Hyperplasia Osteoporosis	Drug: Bazedoxifene/Conjugate Estrogens (CE) Drug: Raloxifene Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Estrogens, conjugated Raloxifene hydrochloride Raloxifene Bazedoxifene

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	3544
Study Start Date:	April 2002
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Bazedoxifene/Conjugate Estrogens (CE)
B: Active Comparator	Drug: Raloxifene
C: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675688

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided by Wyeth

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lobo RA, Pinkerton JV, Gass ML, 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):1025-38. Epub 2009 Jul 26.

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3115A1-303
Study First Received:	May 7, 2008
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00675688 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Menopause

Additional relevant MeSH terms:

Estrogen Antagonists
Estrogens
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Uterine Diseases
Bone Density Conservation Agents
Bone Diseases, Metabolic
Selective Estrogen Receptor Modulators
Bone Diseases

Hormones
Pharmacologic Actions
Genital Diseases, Female
Estrogen Receptor Modulators
Hyperplasia
Estrogens, Conjugated (USP)
Raloxifene
Pathologic Processes
Musculoskeletal Diseases
Endometrial Hyperplasia

ClinicalTrials.gov processed this record on November 22, 2009