Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis - Full Text View

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00808132

Purpose

The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.

Condition	Intervention	Phase
Menopause Osteoporosis	Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg Drug: bazedoxifene 20 mg Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Menopause Osteoporosis

Drug Information available for: Estrogens, conjugated Medroxyprogesterone 17-acetate Prempro Bazedoxifene Medroxyprogesterone

U.S. FDA Resources

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

Primary Outcome Measures:

Incidence of Endometrial Hyperplasia and Changes in Bone Mineral Density [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Breast Density, Incidence of Uterine Bleeding, Incidence of Breast Tenderness [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment:	1902
Study Start Date:	January 2009
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 bazedoxifene 20 mg/conjugated estrogens 0.45 mg	Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.
Experimental: 2 bazedoxifene 20 mg/conjugated estrogens 0.625 mg	Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.
Experimental: 3 bazedoxifene 20 mg	Drug: bazedoxifene 20 mg One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.
Active Comparator: 4 Prempro	Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year. Other Name: Prempro
Placebo Comparator: 5 Placebo	Drug: Placebo One capsule, placebo (over-encapsulated), once a day for one year.

Eligibility

Ages Eligible for Study:	40 Years to 64 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for menopausal symptoms
At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels > 40 mIU/mL
Intact Uterus

Exclusion Criteria:

Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening
A history or active presence of clinically important medical disease: eg. cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast cancer, etc.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808132

Show 178 Study Locations

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:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00808132 History of Changes
Other Study ID Numbers:	3115A1-3307, B2311009
Study First Received:	December 12, 2008
Last Updated:	March 9, 2011
Health Authority:	United States: Food and Drug Administration

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

Postmenopausal Women
Bazedoxifene/Conjugated Estrogens

Additional relevant MeSH terms:

Endometrial Hyperplasia
Osteoporosis
Osteoporosis, Postmenopausal
Uterine Diseases
Genital Diseases, Female
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Estrogens, Conjugated (USP)
Estrogens
Medroxyprogesterone Acetate
Medroxyprogesterone
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on February 09, 2012