Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00242710

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/Conjugated Estrogen Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo- And Active-Controlled Efficacy And Safety Study Of Bazedoxifene/Conjugated Estrogens Combinations For Prevention Of Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Estrogens, conjugated Bazedoxifene

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Incidence of hyperplasia as assessed by endometrial biopsies at screening and 1 year [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
For the osteoporosis substudy, bone mineral density of the spine and hip as measured at screening and 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Uterine bleeding/spotting and breast pain at screening and through 1 year (by diary) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	870
Study Start Date:	September 2005
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator BZA 20mg/CE 0.625	Drug: Bazedoxifene/Conjugated Estrogen BZA 20mg/CE 0.625mg daily oral administration, BZA 20mg/CE 0.45, CE 0.45mg/MPA1.5mg
Arm 2: Active Comparator BZA 20mg/CE 0.45	Drug: Bazedoxifene/Conjugated Estrogen BZA 20mg/CE 0.625mg daily oral administration, BZA 20mg/CE 0.45, CE 0.45mg/MPA1.5mg
Arm 3: Active Comparator CE 0.45mg/MPA1.5mg	Drug: Bazedoxifene/Conjugated Estrogen BZA 20mg/CE 0.625mg daily oral administration, BZA 20mg/CE 0.45, CE 0.45mg/MPA1.5mg
Arm 4: Placebo Comparator Placebo	Other: Placebo Placebo

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Generally healthy, postmenopausal women, aged 40 to less than 65 years
Intact uterus
At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels > 40 mIU/mL.

Exclusion Criteria:

Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening (12 weeks for the osteoporosis substudy)
A history or active presence of clinically important medical disease
Malabsorption disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242710

Locations

United States, California

Upland, California, United States, 91786
United States, Florida

Inverness, Florida, United States, 34452

West Palm Beach, Florida, United States, 33409
United States, Georgia

Decatur, Georgia, United States, 30033
United States, Hawaii

Honolulu, Hawaii, United States, 96814
United States, Kentucky

Lexington, Kentucky, United States, 40536-0293
United States, Montana

Billings, Montana, United States, 59102
United States, Oregon

Eugene, Oregon, United States, 97401
United States, Pennsylvania

Pittsburgh, Pennsylvania, United States, 15206

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3115A1-304
Study First Received:	October 18, 2005
Last Updated:	September 24, 2009
ClinicalTrials.gov Identifier:	NCT00242710 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Endometrium
Uterus
Menopause

Additional relevant MeSH terms:

Estrogens
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Uterine Diseases
Bone Diseases, Metabolic
Bone Diseases
Hormones

Pharmacologic Actions
Genital Diseases, Female
Hyperplasia
Estrogens, Conjugated (USP)
Pathologic Processes
Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Endometrial Hyperplasia

ClinicalTrials.gov processed this record on February 08, 2010