Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation

Wyeth is now a wholly owned subsidiary of Pfizer76 enrolled

Overview

The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® \[TM\]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Menopause

Interventions

Premarin®/MPA formulation ADRUG

Premarin®/MPA formulation BDRUG

Premarin®/MPA formulation CDRUG

Premarin®/MPA currently marketed product

Eligibility

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

Medical Language ↔ Plain English

Inclusion 1. Healthy postmenopausal women aged 35 to 70. 2. Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg. 3. Nonsmoker or smoker of fewer than 10 cigarettes/day. Exclusion 1. History or presence of hypertension (\>139 mm Hg systolic or \>89 mm Hg diastolic). Can take up to 2 antihypertensive medications to keep blood pressure under control. 2. History within 1 year of study day 1 of alcohol or drug abuse. 3. Use of any investigational drug within 30 days before study day 1.

Outcomes

Primary Outcomes

Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations

Time frame: 14 weeks

Secondary Outcomes

No secondary outcome

Time frame: No time frame

Data from ClinicalTrials.gov

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