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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Postmenopause

Treatments: Drug: Premarin/MPA; Drug: Provera 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00543634

0713E1-1138

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: Female

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: Premarin/MPA

Drug: Premarin/MPA

2

Active Comparator group

Treatment:

Drug: Provera 10 mg