Status:
COMPLETED
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Postmenopausal Osteoporosis
Postmenopause
Eligibility:
FEMALE
35-70 years
Phase:
PHASE1
Brief Summary
This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and m...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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 5 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00381251
Start Date
September 1 2006
End Date
January 1 2007
Last Update
June 11 2007
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