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

Tracking Information

First Received Date ^ICMJE

October 3, 2007

Last Updated Date

July 8, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA). [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00543634 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Health Services Research, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

Condition ^ICMJE

Postmenopause

Intervention ^ICMJE

Drug: Premarin/MPA
Drug: Provera 10 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 ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2008

Estimated Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

35 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Trial Manager

clintrialparticipation@wyeth.com

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00543634

Responsible Party

Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth

Study ID Numbers ^ICMJE

0713E1-1138

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

MDS Pharma Services

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP