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This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and medroxyprogesterone, Premproâ„¢.
Prempro is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin and MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic blood samples for unconjugated and total (unconjugated plus conjugated) estrogens and MPA will be obtained. The following pharmacokinetic parameters will be determined: Cmax, Tmax, t½, AUC0-T, AUC0-¥. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trial Manager | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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