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

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 Drug: CE 0.45 mg/MPA 1.5mg Other: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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 ]
Additional safety and efficacy data at 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment:	1083
Study Start Date:	September 2005
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 BZA 20mg/CE 0.625	Drug: Bazedoxifene/Conjugated Estrogen Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Experimental: Arm 2 BZA 20mg/CE 0.45	Drug: Bazedoxifene/Conjugated Estrogen Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Active Comparator: Arm 3 CE 0.45mg/MPA1.5mg	Drug: CE 0.45 mg/MPA 1.5mg Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Placebo Comparator: Arm 4 Placebo	Other: Placebo Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

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
Pfizer Investigational Site
Upland, California, United States, 91786
United States, Florida
Pfizer Investigational Site
Inverness, Florida, United States, 34452
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Georgia
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40536-0293
United States, Montana
Pfizer Investigational Site
Billings, Montana, United States, 59102
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15206

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00242710 History of Changes
Other Study ID Numbers:	3115A1-304
Study First Received:	October 18, 2005
Last Updated:	February 6, 2013
Health Authority:	United States: Food and Drug Administration

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

Endometrium
Uterus
Menopause

Additional relevant MeSH terms:

Endometrial Hyperplasia
Hyperplasia
Osteoporosis
Adenoma
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Estrogens, Conjugated (USP)
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013