Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

Pfizer

Status and phase: Completed; Phase 3

Conditions: Osteoporosis; Endometrial Hyperplasia

Treatments: Drug: Bazedoxifene/Conjugated Estrogen; Other: Placebo; Drug: CE 0.45 mg/MPA 1.5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00242710

3115A1-304

Details and patient eligibility

About

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.

Enrollment: 1,083 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,083 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

BZA 20mg/CE 0.625

Treatment:

Drug: Bazedoxifene/Conjugated Estrogen

Drug: Bazedoxifene/Conjugated Estrogen

Arm 2

Experimental group

Description:

BZA 20mg/CE 0.45

Treatment:

Drug: Bazedoxifene/Conjugated Estrogen

Drug: Bazedoxifene/Conjugated Estrogen

Arm 3

Active Comparator group

Description:

CE 0.45mg/MPA1.5mg

Treatment:

Drug: CE 0.45 mg/MPA 1.5mg

Arm 4

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo