NCT00472927CompletedPhase 1
An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Three New Formulations of Premarin 0.45mg/Medroxyprogesterone Acetate (MPA) 1.5mg Compared With a Reference Formulation of Premarin/MPA (PremproTM) 0.45mg/1.5mg in Healthy Postmenopausal Women
Wyeth is now a wholly owned subsidiary of Pfizer1 site in 1 countryStarted: May 1, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Locations
- 1
- Primary Endpoint
- Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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