NCT00154180

Kronos Early Estrogen Prevention Study (KEEPS)

Effects of Estrogen Replacement on Atherosclerosis Progression in Recently Menopausal Women

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 728 (estimated)
• Sponsor: Kronos Longevity Research Institute · Academic / Other
• Sex: Female
• Age: 42 Years – 58 Years
• Healthy volunteers: Accepted

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.

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 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 0.45 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 accrual 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.

Conditions

• Menopause
• Arteriosclerosis

Interventions

Type	Name	Description
DRUG	Conjugated equine estrogens 0.45 mg/day	Pill, 1 pill taken daily each month for the study duration
DRUG	Transdermal estradiol, 50 mcg/day	Patch; 1 patch is applied to the skin weekly. Patch site is rotated on a weekly basis.
DRUG	Micronized progesterone, 200 mg/day x 12 d/month	capsule, 1 capsule taken daily for the first 12 days of each month for the study duration
DRUG	CEE , progesterone, estradiol patch or placebo for each	CEE 0.45mg 1 PO QD Progesterone 200 mg 1 PO HS first 12 days of the month estradiol patch use 1 per week
DRUG	CEE, progesterone, transdermal patch or the placebo	CEE 0.45 mg 1 PO QD or placebo equivalent Prometrium 200 mg 1 PO qHS for first 12 dasy of each month or placebo equivalent transdermal patch 0.05 mg use 1 patch per week or placebo equivalent

Timeline

• Start date: 2005-09-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2005-09-12
• Last updated: 2009-09-14

Locations

9 sites across 1 country: United States