Changes in the blood coagulation system were studied in three groups of 20 patients each. The first group received 0.5 mg. of norethindrone daily, plus 0.06 mg. of ethinyl estradiol on alternate days from cycle Day 5 through 25. The second group, all of whom had been fitted with an intrauterine contraceptive device (IUD), received no hormonal treatment and served as a control group. The third group received 0.5 mg. of norethindrone daily, combined with 0.045 mg. of ethinyl estradiol given on alternate days from cycle Day 5 through 25. Blood samples were drawn prior to the initiation of the study and after three months of treatment. Tests of the following parameters of the blood coagulation system were performed: direct platelet count; platelet adhesiveness; prothrombin time; thrombin time; fibrinogen; factor II assay; activity of factors V, VII, VIII, IX, and X; antithrombin III; and fibrin/fibrinogen degradation products. For a number of these factors, both fresh and frozen blood samples were examined. It was concluded that the two treatment regimens, with the use of alternate-day estrogen administration over a three-month period, had no clinically significant effect on the blood coagulation system.
PIP: The effect of combined, low-dose oral contraceptives on blood coagulation factors was studied in 60 healthy women. 20 women received .5 mg/day norethindrone plus .06 mg ethinyl estradiol on alternate days of the cycle from Days 5 through 25, another group of 20 received an IUD, and a 3rd group of 20 received .5 mg/day norethindrone plus .045 mg ethinyl estradiol on alternate days of the cycle from Days 5 through 25. Blood samples were taken before and after 3 months of treatment. No clinically significant (P greater than .05) effect of either treatment regimen on such blood coagulation factors as platelet count, platelet adhesiveness, prothrombin time, thrombin time, fibrinogen, Factor 2 assay, Factors 5, 7, 8, 9, and 10, and fibrin/fibrinogen degradation products could be established. Both fresh and frozen blood samples were used in the study.