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

June 17, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Open-Label, Single-Dose, Partially Randomized, 6-Period, 6-Treatment, Crossover Bioavailability Study of 3 Pilot Formulations of Premarin®/Medroxyprogesterone Acetate (MPA) Compared With Reference Formulations of Premarin®/MPA (PREMPRO®) and MPA Suspension (Provera®) in Healthy Postmenopausal Women

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: Provera 10 mg
2.5 mg of MPA, 4 tablets dissoved in water
Active Comparator: 1
Drug: Premarin/MPA
0.625 mg/2.5 mg X4
Drug: Premarin/MPA
0.625 mg/5 mg X 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators

MDS Pharma Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

October 3, 2007

First Submitted That Met QC Criteria

October 11, 2007

First Posted (Estimate)

October 15, 2007

Study Record Updates

Last Update Posted (Estimate)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 17, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0713E1-1138

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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