Status:
UNKNOWN
Kronos Early Estrogen Prevention Study (KEEPS)
Lead Sponsor:
Kronos Longevity Research Institute
Collaborating Sponsors:
Albert Einstein College of Medicine
Brigham and Women's Hospital
Conditions:
Menopause
Arteriosclerosis
Eligibility:
FEMALE
42-58 years
Phase:
PHASE4
Brief 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 transitio...
Detailed Description
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 atheroscleroti...
Eligibility Criteria
Inclusion
- menses absent for at least 6 months and no more than 36 months
- good general health
- plasma FSH level greater than or equal to 35 mIU/ml
- estradiol levels \< 40 pg/ml
- normal mammogram within 1 year of randomization
Exclusion
- use of hormone replacement or supplement within 3 months of randomization
- endometrial thickness \>5 mm by vaginal ultrasound
- in utero exposure to diethylstilbestrol (DES)
- current smoking \> 10 cigarettes/day
- obesity-body mass index \> 35
- history of clinical cardiovascular disease
- history of cerebrovascular disease
- history of thromboembolic disease
- coronary calcium score ≥ 50 units
- dyslipidemia-LDL cholesterol \>190 mg/dl
- hypertriglyceridemia-triglycerides \>400 mg/dl
- lipid lowering medication (statin, fibrate,or \> 500 mg/day of niacin)
- nut allergy (Prometrium includes peanut oil)
- uncontrolled hypertension-systolic BP \>150 and/or diastolic BP \> 95
- hysterectomy
- history of, or prevalent, chronic diseases including any cancer (other than basal cell skin cancers), renal failure, cirrhosis, diabetes mellitus, and endocrinopathies other than adequately treated thyroid disease
- known HIV infection and/or medications for HIV infection
- results of any safety laboratory test chemistries, (TSH, CBC, U/A) more than 20% abnormal
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
728 Patients enrolled
Trial Details
Trial ID
NCT00154180
Start Date
September 1 2005
End Date
July 1 2012
Last Update
September 14 2009
Active Locations (9)
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1
Kronos Longevity Research Institute
Phoenix, Arizona, United States, 85016-3452
2
University of California, San Francisco
San Francisco, California, United States, 94115
3
Yale University Medical Center
New Haven, Connecticut, United States, 06519
4
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215