Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)
NCT00472927 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2007-12-06
Summary
To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).
Conditions
- Postmenopause
Interventions
- DRUG
-
Premarin/MPA 0.45 mg/1.5 mg
Sponsors & Collaborators
-
Wyeth is now a wholly owned subsidiary of Pfizer
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 35 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-05-31
- Completion
- 2007-08-31
Countries
- United States
Study Locations
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