Kronos Early Estrogen Prevention Study (KEEPS)

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: Female

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 transition.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kronos Longevity Research Institute
• Collaborators: Albert Einstein College of Medicine; 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
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Estrogens, Conjugated (USP); Polyestradiol phosphate; Progesterone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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