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

Last updated on February 16, 2019

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Study Location
Miami, Florida, 33126 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postmenopause
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00472927
Pfizer
Completed
Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

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