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| Sponsors and Collaborators: |
Kronos Longevity Research Institute Albert Einstein College of Medicine of Yeshiva University Brigham and Women's Hospital Columbia University Mayo Clinic University of California, San Francisco University of Utah University of Washington Yale University |
|---|---|
| Information provided by: | Kronos Longevity Research Institute |
| ClinicalTrials.gov Identifier: | NCT00154180 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Menopause Arteriosclerosis |
Drug: Conjugated equine estrogens 0.45 mg/day Drug: Transdermal estradiol, 50 mcg/day Drug: Micronized progesterone, 200 mg/day x 12 d/month |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Effects of Estrogen Replacement on Atherosclerosis Progression in Recently Menopausal Women |
| Estimated Enrollment: | 720 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | June 2010 |
The KEEPS is designed to explore the hypothesis that early initiation of hormone therapy, in women who are at the inception of their menopause, will decrease the rate of accumulation of atherosclerotic plaque, indicating a likely delay in the onset of clinical cardiovascular disease. The study is designed as a multicenter, 4 year randomized clinical trial. It will evaluate the effectiveness of of 0.45 mg/day of oral conjugated equine estrogens or 50 mcg/day of transdermal estradiol via skin patch changed weekly (each in combination with cyclic oral, micronized progesterone, 200 mg daily for 12 days per month), versus placebo in preventing progression of carotid intimal medial thickness by sonogram and the accrual of coronary calcium in women aged 42-58 who are within 36 months of their final menstrual period at initiation of treatment. A number of secondary endpoints including biochemical and genetic risk factors for cardiovascular and thrombotic disease, and effects on cognition will also be studied. The study will enroll a total of 720 women in 2005-6, with an anticipated completion of the trial in 2010.
Eligibility| Ages Eligible for Study: | 42 Years to 58 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Patricia Crenshaw, BA | (866) 878-1221 | info@kronosinstitute.org |
| Contact: Mary Barksdale, CNM, CCRP | (602) 778-7487 |
| United States, California | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Nancy Jancar, RN 415-353-4300 keepstudy@ucsfmedctr.org | |
| Principal Investigator: Marcelle I Cedars, MD | |
| United States, Connecticut | |
| Yale University | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Diane Wall, RN 203-737-5169 diane.wall@yale.edu | |
| Principal Investigator: Hugh S Taylor, MD | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Kathryn Kalan, RN 617-732-9871 kkalan@partners.org | |
| Principal Investigator: JoAnn E Manson, MD, DrPH | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Teresa Zais, RN 507-538-0848 zais.teresa@mayo.edu | |
| Principal Investigator: Virginia E Miller, PhD | |
| United States, New York | |
| Columbia Presbyterian Hospital | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Amber Ahmad, MPH 212-305-9672 aa2430@columbia.edu | |
| Contact: Luz Sanabria 212-305-9672 ls2328@columbia.edu | |
| Principal Investigator: Roger Lobo, MD | |
| Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Barbara Isaac, RN 718-430-8656 bisaac@aecom.yu.edu | |
| Principal Investigator: Nanette F Santoro, MD | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84108 | |
| Contact: Stacey Larrinaga-Shum 801-581-3888 ext 249 Stacey.Larrinaga-shum@hsc.utah.edu | |
| Principal Investigator: Eliot Brinton, MD | |
| United States, Washington | |
| University of Washington/VA Puget Sound, HCS | Recruiting |
| Seattle/Tacoma, Washington, United States, 98493 | |
| Contact: Colleen Carney, RN 253-583-2040 tiscolleen@yahoo.com | |
| Contact: Suzanne Barsness, RN 206-543-3897 barsness@u.washington.edu | |
| Principal Investigator: George R Merriam, MD | |
| Study Director: | S Mitchell Harman, MD, PhD | Kronos Longevity Research Institute |
| Study Director: | Frederick Naftolin, MD, PhD | Kronos Longevity Research Institute |
| Principal Investigator: | Michael Mendelsohn, MD | Tufts Medical Center |
| Principal Investigator: | Howard Hodis, MD | University of Southern California |
| Principal Investigator: | Matthew Budoff, MD | University of California, Los Angeles |
| Principal Investigator: | Sanjay Asthana, MD | University of Wisconsin, Madison |
| Principal Investigator: | Dennis M Black, PhD | University of California, San Francisco |
More Information
| Study ID Numbers: | KLRI-04-1, WIRB Protocol #20040792 |
| Study First Received: | September 7, 2005 |
| Last Updated: | May 3, 2006 |
| ClinicalTrials.gov Identifier: | NCT00154180 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Perimenopause Coronary Disease Estrogen Replacement Therapy Hormone Replacement Therapy |
|
Atherosclerosis Arterial Occlusive Diseases Estrogens Progesterone Hormone Antagonists Estradiol valerate Hormones, Hormone Substitutes, and Hormone Antagonists Disease Progression Vascular Diseases Arteriosclerosis |
Estradiol 17 beta-cypionate Hormones Estradiol Coronary Disease Estrogens, Conjugated (USP) Progestins Estradiol 3-benzoate Polyestradiol phosphate Coronary Artery Disease Menopause |
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Arterial Occlusive Diseases Estrogens, Conjugated (USP) Estrogens Progesterone Progestins Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Vascular Diseases Cardiovascular Diseases Arteriosclerosis Hormones Pharmacologic Actions |
