Status:
COMPLETED
Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Postmenopause
Eligibility:
FEMALE
35-70 years
Phase:
PHASE1
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00472927
Start Date
May 1 2007
End Date
August 1 2007
Last Update
December 6 2007
Active Locations (1)
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1
Miami, Florida, United States, 33126