Showing papers by "Ronald T. Burkman published in 1993"

Metabolic effects and efficacy of a triphasic oral contraceptive (norgestimate/ethinyl estradiol).

Abstract: Physicians in North Carolina and in Michigan conducted clinical trials on 1783 women aged 17-38 for 24 cycles to determine the efficacy and safety of a triphasic oral contraceptive (35 mcg ethinyl estradiol + 180 215 and 250 mcg norgestimate) (brand names: Ortho Tri-Cyclen Tri-Cilest). The proportion of subjects with average menstrual flow increased from 58% to 72%. Breakthrough bleeding fell from 6.8% during the first cycle to 2.4% at 24 cycles. Total bleeding and/or spotting also decreased. Serum lipid levels at 1 and 2 years were significantly greater than baseline levels (p < 0.05). Since the percentage increase in high density lipoprotein (HDL) cholesterol at 1 and 2 years was several times greater than that of low density lipoprotein (LDL) cholesterol the HDL/LDL ratio improved from 0.40 to 0.44 (p < 0.05). This improved HDL/LDL ratio indicates that this triphasic OC may prevent atherogenesis and myocardial infarction. The increases in the cholesterol fractions indicated an estrogenic effect of the OC. The area under the curve (AUC) for plasma glucose increased between baseline and 12 months (p < 0.05) but the 24 month AUC was slightly less than that of baseline. One-year plasma insulin AUC was higher than that of baseline but not significantly so. The 2-year plasma insulin AUC was even lower than that of baseline plasma insulin. Only 4.3% discontinued the OC because of bleeding disorders suggesting good cycle control.