Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

Completed · Phase 1

Conditions studied: Postmenopause

In brief

To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).

Key facts

Study ID

NCT00472927

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

Starts

2007-05-01

Expected to finish

2007-08-01

Last updated by the study team

2007-12-06

Who can join

Age: 35 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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