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

Wyeth is now a wholly owned subsidiary of Pfizer

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Postmenopause

Interventions

Premarin/MPA 0.45 mg/1.5 mgDRUG

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Miami, Florida, United States

Outcomes

Primary Outcomes

Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.