Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)
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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
Study Start Date :
Actual Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
35 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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