This is a prospective, randomized, double-blinded clinical trial designed to compare the short-term effect of Raloxifene or Hormone Replacement Therapy (HRT) on serum lipids and lipoproteins of dyslipidemic postmenopausal women over time. Subjects will be randomized to receive either raloxifene 60 mg/d or conjugated equine estrogen 0.625 mg plus consecutive medroxyprogesterone acetate 2.5 mg/day (HRT). Serum lipoprotein(a), low-density lipoproteins, high-density lipoproteins, total cholesterol and triglycerides will be obtained at baseline, 3 months, and 6 months. The beneficial short-term effects of HRT on lipids and lipoproteins of dyslipidemic women has been established via clinical trials; however, the potential adverse effects of breast and endometrial cancer, hot flashes, and vaginal bleeding have been reported. Raloxifene is a selective estrogen receptor modulator that has estrogen-agonist effect on bone and estrogen antagonist effects on breast and uterus. Short term trials have demonstrated raloxifene reduces LDL and Lp(a) in healthy postmenopausal women with normal lipid panels. This study will add to the scientific body of evidence regarding raloxifene as a potential primary prevention alternative for dyslipidemic postmenopausal women.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Predoctoral Individual National Research Service Award (F31)
Project #
5F31NR007564-02
Application #
6539449
Study Section
National Institute of Nursing Research Initial Review Group (NRRC)
Program Officer
Armstrong, Nell
Project Start
2002-03-29
Project End
Budget Start
2002-03-29
Budget End
2003-03-28
Support Year
2
Fiscal Year
2002
Total Cost
$25,519
Indirect Cost
Name
University of Nebraska Medical Center
Department
Miscellaneous
Type
Schools of Nursing
DUNS #
City
Omaha
State
NE
Country
United States
Zip Code
68198