Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 10, 2007

Last Updated Date

December 4, 2007

Start Date ^†

May 2007

Current Primary Outcome Measures ^†

Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00472927 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)

Official Title ^†

An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Three New Formulations of Premarin 0.45mg/Medroxyprogesterone Acetate (MPA) 1.5mg Compared With a Reference Formulation of Premarin/MPA (PremproTM) 0.45mg/1.5mg in Healthy Postmenopausal Women

Brief Summary

To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Crossover Assignment

Condition ^†

Postmenopause

Intervention ^†

Drug: Premarin/MPA 0.45 mg/1.5 mg

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

August 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Healthy, postmenopausal women, aged 35 to 70 years
Spontaneous amenorrhea for at least 12 months (no FSH required) or spontaneous amenorrhea for at least 6 months (FSH level ≥38 mIU/mL); spontaneous amenorrhea must have begun by the age of 55
BMI in the range of 18 to 35 kg/m2

Exclusion Criteria:

History or presence of hypertension (>139 mm Hg systolic or >89 mm Hg diastolic)
History of drug allergy to conjugated estrogens (CE) or selective estrogen receptor modulators (SERMs)
Use of prescription or investigatioanl drugs within 30 days before test article administration

Gender

Female

Ages

35 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00472927

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Wyeth

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.