Trial Name: Kronos Early Estrogen Prevention Study (KEEPS)

Type of Study: Menopause/Hormone

Summary:
Dr. Marcelle I. Cedars from the UCSF Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology, along with 7 other investigators at prominent medical centers around the country, will be conducting a study called the Kronos Early Estrogen Prevention Study (KEEPS). KEEPS is a 5 year study in which the investigators hope to learn whether estrogen treatment slows hardening of the arteries (atherosclerosis) in women if started soon after menopause. Atherosclerosis (hardening of the arteries) is the disease process that causes most heart attacks. KEEPS will also test for other possible good and bad effects of estrogen relative to heart disease. This is an Investigator-Initiated study meaning that the investigators have initiated and designed the study without any other influences. KEEPS is funded by the Aurora Foundation (a private foundation with no pharmaceutical affiliations), and is Sponsored by the Kronos Longevity Research Institute (KLRI) in Phoenix, Arizona who will be functioning as the Coordinating Center throughout the study.

Principal Investigator: Marcelle I. Cedars, M.D.

Study Duration: 5 years
Anticipated Start Date: Fall 2005
Anticipated End Date: Fall 2010/2011

Recruitment Goal: 90 participants

Qualifications:
• 42-58 years of age
• No menses (period) for at least 6 months and no more than 36 months (or 3 years)
• Last spontaneous menses (period) occurring after age 40
• Good general health
• Normal mammogram within 1 year of entering the study
• Have not used menopausal hormone therapy in the last three months (otherwise washout period required)
• Have not had a hysterectomy.

Time Requirement:
Approximately 23 visits over a 5 year period.
(8 visits - 4 to 6 hours each, and 15 visits - approx. 1 hour each)
All visits, with the exception of two, will take place at various locations on the UCSF campus in SF. Two visits, one at the beginning and one at the end of the study, will take place within an hour from the UCSF campus. Visits will include procedures such as blood draws, physical exams including pelvic examination and pap smear, mammograms, vaginal ultrasound, as well as non-invasive scans to evaluate your heart health (Carotid intimal medial thickness by high resolution B mode ultrasonography, and the measurement of coronary calcium by Electron Beam Computerized Tomography). There will also be Cognitive testing throughout the 5 years.

Reimbursement:
*$25.00 for each Short Study/Safety Visit (13) and for each Screening visit (2) - (15 total)
*$50.00 for Baseline and for each Long Study Visit (7) - (8 total)
Maximum reimbursement: $775 if participant completes all study visits over 5 year period

Contact:
Project Director:
Nancy Jancar, R.N.
Email: keepstudy@ucsfmedctr.org
(415) 353-4300

KEEPS website: www.keepstudy.com