Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)
Study Details
Study Description
Brief Summary
To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components) []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy, postmenopausal women, aged 35 to 70 years
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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
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BMI in the range of 18 to 35 kg/m2
Exclusion Criteria:
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History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)
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History of drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)
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Use of prescription or investigatioanl drugs within 30 days before test article administration
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Miami | Florida | United States | 33126 |
Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0713E1-1142