Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study

Summary

The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study as a core lab coordinating center, the investigators will be performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript.

The main trial duration: December 1999 - May 2003.

The ancillary data analysis project duration: April 2006 - March 2010.

Conditions

• Myocardial Ischemia

Interventions

DRUG

1/10 NA/EE

Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE)

DRUG

Placebo

1 mg placebo

Sponsors & Collaborators

• Parke-Davis

  collaborator INDUSTRY

• University of Pittsburgh

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Allegheny University

  collaborator UNKNOWN

• University of Alabama at Birmingham

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Cedars-Sinai Medical Center

  lead OTHER

Principal Investigators

• C. Noel Bairey Merz, MD · Cedars-Sinai Medical Center

• Carl Pepine, MD · University of Florida

• Steve Reis, MD · University of Pittsburgh

• Nathaniel Reichek, MD · Allegheny University of the Health Sciences

• William Rogers, MD · University of Alabama at Birmingham

• Vijay Misra, MD · University of Alabama at Birmingham

• Robert B Weiss, MD · Johns Hopkins University

• Sheryl Kelsey, PhD · University of Pittsburgh

• George Sopko, MD · National Institute of Health (WISE Project Officer)

• James Symons, PhD · Parke-Davis

• Connie McLaughlin, PharmD · Parke-Davis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-12-31

Primary Completion

2003-05-31

Completion

2010-03-31

Countries

• United States

Study Locations