Evidence from previous cross-sectional and prospective studies on the effect of levonorgestrel implant (Norplant) use on the cardiovascular risk factor profile of premenopausal women is indeterminate. To date no randomized clinical trial has been conducted directly comparing the effects of levonorgestrel implant use to oral contraceptive use on the cardiovascular risk profile of premenopausal women. We hypothesize that levonorgestrel implant use when compared with use of a low dose oral contraceptive (Triphasil), which contains both ethinyl estradiol and levonorgestrel, may have an adverse effect on lipid metabolism, resulting in a decrease in total high density lipoprotein (especially the HDL-2 subfraction), a decrease in apolipoprotein A1, an increase in low density lipoprotein, and an increase in apolipoprotein B. We also hypothesize that levonorgestrel implant use when compared with use of a low dose oral contraceptive (Triphasil) may: (1) have an adverse effect on blood pressure resulting in an increased risk of hypertension; (2) have an adverse effect on glucose metabolism resulting in hyperglycemia and hyperinsulinemia; and (3) have an adverse effect on the coagulation system resulting an increased risk of a hypercoagulable state, with subsequent increased risk of both thromboembolic and atherosclerotic disease. This proposed randomized clinical trail provide a rigorous test of whether levonorgestrel implant use compared to use of a state of the are oral contraceptive increases cardiovascular risk factors in premenopausal women.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD029478-04
Application #
2403276
Study Section
Epidemiology and Disease Control Subcommittee 2 (EDC)
Project Start
1994-05-01
Project End
1999-04-30
Budget Start
1997-05-01
Budget End
1999-04-30
Support Year
4
Fiscal Year
1997
Total Cost
Indirect Cost
Name
University of Tennessee Health Science Center
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
941884009
City
Memphis
State
TN
Country
United States
Zip Code
38163
Tylavsky, F A; Johnson, K C; Wan, J Y et al. (1998) Plasma renin activity is associated with bone mineral density in premenopausal women. Osteoporos Int 8:136-40