Status:
COMPLETED
Estrogen, HDL, and Coronary Heart Disease in Women
Lead Sponsor:
Tufts University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cardiovascular Diseases
Coronary Disease
Eligibility:
FEMALE
55-80 years
Phase:
PHASE2
PHASE3
Brief Summary
To clarify the effects of estrogen, with or without progestin, on high density lipoprotein (HDL) in postmenopausal women.
Detailed Description
BACKGROUND: Coronary heart disease (CHD) is the leading cause of death and disability in postmenopausal women in the United States. Low plasma levels of high-density lipoprotein cholesterol (HDL-C) a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- age \>55 years without natural menses for at least 5 years or a serum FSH levels \>40 IU/L without natural menses for at least 1 y or bilateral oophorectomy documented coronary artery disease
- Exclusion criteria:
- history of breast or endometrial carcinoma history of deep-vein thrombosis or pulmonary embolism previous or planned coronary bypass gallstones fasting TG levels \>400 mg/dl uncontrolled diabetes uncontrolled hypertension serum creatinine \>2 mg/dl a \>70% stenosis of the left main coronary artery.
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT00083824
Start Date
March 1 2004
End Date
February 1 2007
Last Update
April 21 2016
Active Locations (1)
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1
HNRCA at Tufts University
Boston, Massachusetts, United States, 02111