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Therapeutic Areas: Obstetrics/Gynecology | Endocrinology
Disease Category: Menopause

Trial Information

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

This is a research study to evaluate the efficacy and safety of an investigational drug for post-menopausal women.

Patient Inclusion Criteria:

• Healthy, postmenopausal females between the ages of 40 and 64, seeking treatment for menopausal symptoms:
• 12 months of spontaneous amenorrhea, or
• 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels greater than 40 mIU/mL
• Intact uterus
• Endometrial biopsy report (performed on behalf of study)
• Agrees to comply to study protocol and complete all study visits

Patient Exclusion Criteria:

• Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within the last 8 weeks; use of transdermal hormone products within the last 8 weeks or 12 weeks (call for more information); use of vaginal hormone products (rings, creams, gels) within the last 4 weeks or 12 weeks (call for more information); use of intrauterine progestins within the last 12 weeks; use of progestin implants/injectables or estrogen pellets/injectables within the last 6 months.
• History of hypersensitivity to estrogens or progestins, chronic disease, malignancy or abnormal physical exam

Jessica Torres, Research Study Coordinator
Discovery Clinical Research, Inc.
140 S.W. 84 Avenue, Suite D
Plantation, FL 33324
Phone: (954)452-5850 ext. 109
EMail: jessica.torres@shcr.com

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