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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP); Medroxyprogesterone; Medroxyprogesterone Acetate

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.