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Am J Obstet Gynecol. 1993 May;168(5):1400-6.

Single- and multiple-dose pharmacokinetics of a low-dose oral contraceptive in women with chronic renal failure undergoing peritoneal dialysis.

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Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill.



Our purpose was to compare the pharmacokinetic parameters of oral administration of a 35 micrograms ethinyl estradiol, 1 mg norethindrone pill in peritoneal dialysis patients and normal women.


A single-dose study was performed with five patients and four controls, followed by a multiple-dose study with five subjects in each group. Pharmacokinetic parameters were calculated by noncompartmental analysis and statistical analysis performed with Mann-Whitney U testing.


There is no difference in the pharmacokinetic parameters for norethindrone in peritoneal dialysis patients compared with normal women. During multiple dosing an increased area under the concentration curve and decreased apparent oral clearance was observed for ethinyl estradiol in peritoneal dialysis patients compared with normal women.


Peritoneal dialysis patients have decreased apparent oral clearance of ethinyl estradiol, leading to slightly higher serum concentrations compared with women with normal renal function. The clearance of norethindrone is the same in peritoneal dialysis patients and normal women.


In a single-dose and multiple-dose study, gynecologists from California, North Carolina, and Texas, compared pharmacokinetic parameters of the low dose oral contraceptive (OC), Ortho-Novum 1/35, (35 mcg ethinyl estradiol and 1 mg norethindrone) in premenopausal women with renal failure on peritoneal analysis and in age and weight matched controls. They used Mann-Whitney U testing and noncompartmental analysis to calculate pharmacokinetic parameters. In the multiple-dose study, peritoneal dialysis patients had higher serum levels of ethinyl estradiol than did controls 2, 3, and 12 hours after dosing (p .05). In the same study, no significant differences in norethindrone levels existed, however. Ethinyl estradiol levels were not significantly different between the cases and controls in the single-dose study. In the multiple-dose study, the dialysis patients had a much lower apparent oral clearance and a higher area under the concentration curve than did the controls (296.1 ml/hr x kg vs. 525.8 ml/hr x kg and 1930.2 pg/ml x hr vs. 1071.4 pg/ml x hr, respectively, p = .02). For pharmacokinetics of ethinyl estradiol, multiple dosing significantly increased the elimination of half-life, area under the curve, and mean residence time in both controls and dialysis patients. As for norethindrone, no significant difference between cases and controls in any pharmacokinetic parameter occurred in both the single- and multiple-dose studies. For norethindrone in cases and controls, the area under the curve and the maximum serum concentration increased with multiple dosing. Multiple dosing significantly decreased the clearance/bioavailability of norethindrone in both cases and controls. It increased greatly the mean residence time in dialysis patients. These findings indicated that physicians may administer a low dose OC to peritoneal dialysis patients to manage dysfunctional uterine bleeding or to prevent hypoestrogenemia.

[Indexed for MEDLINE]

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