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The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Premarin®/MPA formulation A | Drug |
| ||
| Premarin®/MPA formulation B |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| No secondary outcome | No time frame |
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Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
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| Premarin®/MPA formulation C | Drug |
|
| Premarin®/MPA currently marketed product | Drug |
|