Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Osteoporosis; Menopause

Treatments: Drug: Placebo; Drug: bazedoxifene 20 mg; Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg; Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg; Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00808132

B2311009

3115A1-3307

Details and patient eligibility

About

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.

Enrollment: 1,886 patients

Sex: Female

Ages: 40 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,886 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

bazedoxifene 20 mg/conjugated estrogens 0.45 mg

Treatment:

Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg

2

Experimental group

Description:

bazedoxifene 20 mg/conjugated estrogens 0.625 mg

Treatment:

Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg

3

Experimental group

Description:

bazedoxifene 20 mg

Treatment:

Drug: bazedoxifene 20 mg

4

Active Comparator group

Description:

Prempro

Treatment:

Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg

5

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo