Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women

Wyeth is now a wholly owned subsidiary of Pfizer30 enrolled

Overview

The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Postmenopause

Interventions

Premarin/MPADRUG

0.625 mg/2.5 mg X4

Premarin/MPADRUG

0.625 mg/5 mg X 2

Provera 10 mgDRUG

2.5 mg of MPA, 4 tablets dissoved in water

Eligibility

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

Medical Language ↔ Plain English

* Healthy postmenopausal women aged 35 to 70 years with spontaneous or surgical amenorrhea * BMI in the range of 18 to 35 kg/m2 * History or presence of hypertension (\>139 mm Hg systolic or \>89 mm Hg diastolic) * History of drug allergy, particularly to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs) * Use of any prescription or investigational drug within 30 days before test article administration

Locations (1)

Unnamed facility

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).

Time frame: 4 days

Data from ClinicalTrials.gov

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