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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Postmenopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Premarin/MPA

Intervention Type DRUG

0.625 mg/2.5 mg X4

Premarin/MPA

Intervention Type DRUG

0.625 mg/5 mg X 2

2

Group Type ACTIVE_COMPARATOR

Provera 10 mg

Intervention Type DRUG

2.5 mg of MPA, 4 tablets dissoved in water

Interventions

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Premarin/MPA

0.625 mg/2.5 mg X4

Intervention Type DRUG

Premarin/MPA

0.625 mg/5 mg X 2

Intervention Type DRUG

Provera 10 mg

2.5 mg of MPA, 4 tablets dissoved in water

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes