Despite over 30 years of research, menopausal hormone replacement therapy (HT) with estrogen or estrogen/progestin remains one of the most controversial areas in medicine. Because the chronic diseases affected by HT (heart disease, breast cancer, stroke, osteoporosis) are among the most common killers and cripplers of women.
Principal Investigator / Coordinating Center
Center Principal Investigators
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Eliot Brinton, MD
Associate Professor of Medicine Cardiovascular Genetics
University of Utah School of Medicine
410 Chipeta Way, Room 167
Salt Lake City, UT 84108
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Marcelle Cedars, MD
Professor, Obstetrics and Gynecology
University of California at San Francisco
UCSF Center for Reproductive Health
2356 Sutter Street, 7th floor
San Francisco, CA 94115-0916
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Rogerio Lobo, MD
Professor, Obstetrics and Gynecology
Columbia University
College of Physicians and Surgeons
622 West 168th Street
New York, NY 10032
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JoAnn Manson, MD, DrPH
Chief, Division of Preventive Medicine
Brigham and Women's Hospital
Professor of Medicine and Professor of Women's Health
Harvard Medical School
900 Commonwealth Avenue, 3rd fl
Boston, MA 02215
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George Merriam, MD
Professor
University of Washington School of Medicine
Research A-151,
VA Puget Sound Sd HCS
9600 Veterans Drive SW (18C/127)
Tacoma, WA 98493
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Virginia Miller, MBA, PhD
Professor and Director
Office of Women's Health
Mayo Clinic
200 First St. S.W.
Rochester, MN 55905
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Hugh S. Taylor, MD
Associate Professor Director of Research in Reproductive Endocrinology and Infertility
Director of the Yale Menopause Program
Division of Reproductive Endocrinology & Infertility Department of Obstetrics, Gynecology and Reproductive Sciences
Yale University
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Nanette Santoro, MD
Professor, Obstetrics and Gynecology
Montefiore Medical Center
Mazer 316, 1300 Morris Park Ave.
Bronx, NY 10461
How does KEEPS differ from the Women's Health Initiative studies?
Women in the WHI studies were 50-79 years old (average 62.7). The women participating in KEEPS will be 42-58 years old with their last menstrual cycle occurring within six months to three years. Thus, KEEPS women will be similar to the women in the many observational trials showing protection against heart disease by HT and less like those in the WHI study. The KEEPS investigators believe this is a critical difference because there are scientific reasons to believe that estrogen may only be effective in protecting against coronary artery disease if it is started early, before the disease gets a chance to develop.
The study is a randomized, placebo-controlled double-blinded, prospective trial with two active treatment groups and one placebo group. It will be a multi-center trial with eight centers around the country at which participants will be entered and followed, and a coordinating center, which oversees and administers the study. Participants will be treated for four years.
Women are randomly assigned to three treatment groups. The medications that are used in KEEPS are 0.45 mg of oral estrogen (Premarin® manufactured by Wyeth) and a transdermal (Climara®) skin patch manufactured by Berlex) as well as a progesterone (Prometrium®, manufactured by Solvay). The progesterone will be given to women on active estrogens only and given the first 12 days of the month.
Summary of inclusion criteria:
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42-58 years of age
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Menses absent for at least six months and no more than three years
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Good general health
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Have not used HT in the last three months or willing to undergo a “wash-out” period
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Have not had a hysterectomy
KEEPS is recruiting now. Once all baseline evaluations are completed, eligible women may begin receiving study medications.
Are there risks or side effects?
Prior to starting any clinical research study, an impartial, independent institutional review board (IRB) must decide that the potential benefits of the information to be obtained justifies the level of risk since there are no guarantees that the medication will be effective.
The principal investigator or study coordinator must explain any potential risks and benefits in detail to prospective participants before they consent to become part of the clinical study. Only the prospective participant can decide whether or not it is appropriate for her to participate.
What is informed consents?
Informed consent is required for participation in clinical studies involving human participants. Individuals are given information about what is involved in the study, including possible benefits and risks. The study coordinator encourages participants to ask questions. After informed consent is reviewed, individuals can make a decision whether or not to participate. The informed consent to participate is then documented in her medical history.
What safety procedures will you include?
Participants will be monitored at three-month intervals by questionnaires administered either during follow-up visits or by telephone contact.
Laboratory monitoring will be carried out at baseline, six months and yearly thereafter.
Participants also will undergo mammography at baseline (if no mammogram is available from the previous year) and then annually.
Are participants required to pay to be in a study?
There is no cost to the women who participate in KEEPS.
Compensation will be provided, please contact a center near you for further information.
How is clinical research funded?
KEEPS is coordinated and funded by KLRI, a not-for-profit research institute, as part of its ongoing commitment to clinical research in aging and age-related diseases. KLRI has no affiliation with any pharmaceutical company.
Can a participant drop from a study at any time?
Just as a participant can decide not to become a participant in the study, she may choose to stop participation at any time.
