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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Estrogens, Conjugated (USP); Medroxyprogesterone Acetate

Criteria

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