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Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation

Last updated on March 15, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Estrogen Replacement Therapy
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 ages 35 to 70 years, inclusive.

- Naturally postmenopausal women must not have had a menstrual period for at least six
months, but less than 12 months, as confirmed by a blood test; or for at least 12
months with no blood hormone test confirmation. Naturally postmenopausal women must
not have had a menstrual period since the age of 54. Surgically menopausal women must
have undergone bilateral oophorectomy (removal of both ovaries) at least 6 months
prior to the start of the study, and the surgical report may be requested to confirm
the surgery date and that the surgery was not due to a cancerous condition.

- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must
be able to abstain from smoking during the inpatient stay.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Healthy, postmenopausal women ages 35 to 70 years, inclusive.

- Naturally postmenopausal women must not have had a menstrual period for at least six
months, but less than 12 months, as confirmed by a blood test; or for at least 12
months with no blood hormone test confirmation. Naturally postmenopausal women must
not have had a menstrual period since the age of 54. Surgically menopausal women must
have undergone bilateral oophorectomy (removal of both ovaries) at least 6 months
prior to the start of the study, and the surgical report may be requested to confirm
the surgery date and that the surgery was not due to a cancerous condition.

- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must
be able to abstain from smoking during the inpatient stay.

NCT00401219
Pfizer
Completed
Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation

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[email protected]

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