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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Postmenopause

Treatments: Drug: Premarin/MPA 0.45 mg/1.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00472927

0713E1-1142

Details and patient eligibility

About

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

Sex: Female

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)