Kronos Early Estrogen Prevention Study (KEEPS)

Summary

The study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.

Conditions

• Menopause
• Arteriosclerosis

Interventions

DRUG

Conjugated equine estrogens 0.45 mg/day

Pill, 1 pill taken daily each month for the study duration

DRUG

Transdermal estradiol, 50 mcg/day

Patch; 1 patch is applied to the skin weekly. Patch site is rotated on a weekly basis.

DRUG

Micronized progesterone, 200 mg/day x 12 d/month

capsule, 1 capsule taken daily for the first 12 days of each month for the study duration

DRUG

CEE , progesterone, estradiol patch or placebo for each

CEE 0.45mg 1 PO QD Progesterone 200 mg 1 PO HS first 12 days of the month estradiol patch use 1 per week

DRUG

CEE, progesterone, transdermal patch or the placebo

CEE 0.45 mg 1 PO QD or placebo equivalent Prometrium 200 mg 1 PO qHS for first 12 dasy of each month or placebo equivalent transdermal patch 0.05 mg use 1 patch per week or placebo equivalent

Sponsors & Collaborators

• Albert Einstein College of Medicine

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Yale University

  collaborator OTHER

• Kronos Longevity Research Institute

  lead OTHER

Principal Investigators

• S Mitchell Harman, MD, PhD · Kronos Longevity Research Institute

• Frederick Naftolin, MD, PhD · Kronos Longevity Research Institute

• Michael Mendelsohn, MD · Tufts Medical Center

• Howard Hodis, MD · University of Southern California

• Matthew Budoff, MD · University of California, Los Angeles

• Sanjay Asthana, MD · University of Wisconsin, Madison

• Dennis M Black, PhD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

42 Years

Max Age

58 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-09-30

Primary Completion

2012-05-31

Completion

2012-07-31

Countries

• United States

Study Locations