Kronos Early Estrogen Prevention Study (KEEPS)

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Menopause, Arteriosclerosis

In brief

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.

Key facts

Study ID

NCT00154180

Run by

Kronos Longevity Research Institute

People needed

728

Starts

2005-09-01

Expected to finish

2012-07-01

Last updated by the study team

2009-09-14

Who can join

Age: 42 and older, up to 58. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kronos Longevity Research Institute — Phoenix, Arizona, United States
• University of California, San Francisco — San Francisco, California, United States
• Yale University Medical Center — New Haven, Connecticut, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Columbia Presbyterian Hospital — New York, New York, United States
• Albert Einstein College of Medicine — The Bronx, New York, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Washington/VA Puget Sound, HCS — Seattle/Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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