Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Three New Formulations of Premarin 0.45mg/Medroxyprogesterone Acetate (MPA) 1.5mg Compared With a Reference Formulation of Premarin/MPA (PremproTM) 0.45mg/1.5mg in Healthy Postmenopausal Women

To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).

Inclusion Criteria:

• Healthy, postmenopausal women, aged 35 to 70 years
• Spontaneous amenorrhea for at least 12 months (no FSH required) or spontaneous amenorrhea for at least 6 months (FSH level ≥38 mIU/mL); spontaneous amenorrhea must have begun by the age of 55
• BMI in the range of 18 to 35 kg/m2

Exclusion Criteria:

• History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)
• History of drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)
• Use of prescription or investigatioanl drugs within 30 days before test article administration