Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)
Phase 1
Completed
- Conditions
- Postmenopause
- Registration Number
- NCT00472927
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)
- Secondary Outcome Measures
Name Time Method