Bioidentical Hormones - U.S. Senate Special Committee on Aging

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%-nicat i nai: nronos Early Estrogen Prevention Study (KEEPS)
ElbiUlty
Study start: September 2005; Expected completion: 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 O.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 aecrual 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.
Ages Eligible for Study: 42 Years - 58 Ycars, Genders Eligible for Study Female
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
* menses absent for at least 6 months and no more thsn 36 months
* good general health
* plasma FSH level greater than or equal to 35 mlU/ml
* estradiol levels < 40 pg/m1
* normal mammogram within I year of randomization
Exclusion Criteria:
* use of hormone replacement or supplement within 3 months of randomization
* endometrial thickness >5 mm by vaginal ultrasound
* in utero exposure to dietrylstilbestrol (DES)
* current smoking> IO cigarettes/day
. obesity-body mass index > 35
* history of clinical cardiovascular disease
* history of cerebrovascular disease
* history of thromboembolic disease
* coronary calcium score 2 50 units
* dyalipidemia-LDL cholesterol >190 mg/dI
* hypertrnglyceidemia-triglycerides >400 mg/dI
* lipid lowering medication (statin fibrateor> 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