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  • Title: A comparative study of the effects of the hemostatic system of two monophasic gestodene oral contraceptives containing 20 micrograms and 30 micrograms ethinylestradiol.
    Author: Winkler UH, Schindler AE, Endrikat J, Düsterberg B.
    Journal: Contraception; 1996 Feb; 53(2):75-84. PubMed ID: 8838483.
    Abstract:
    The effects of two oral contraceptives, containing gestodene and either 20 micrograms or 30 micrograms ethinylestradiol, on hemostatic parameters was investigated in a six-month randomized study involving a total of 40 healthy women between the ages of 18 and 30 years. A large number of hemostatic parameters were measured, which were categorized as either pro-coagulatory, anti-coagulatory, profibrinolytic, anti-fibrinolytic or indicative of fibrin turnover. Additionally, tissue plasminogen activator (t-PA) and plasminogen activator inhibitor (PAI-1) were measured before and after venous occlusion and delta and ratio values calculated. Pro-coagulatory factors as well as reaction products reflecting in vivo coagulatory activity (thrombin-antithrombin III complex, prothrombin fragment 1 + 2) were found to increase. Among the anti-coagulatory parameters, only protein S concentration and protein S activity decreased, most notably in the 30 micrograms EE group. There was a corresponding increase in fibrinolytic activity reflected by reaction products of in vivo fibrinolysis (plasmin-antiplasmin 2-complex, fibrin-degradation products). Measurement of t-PA and PAI-1, before and after venous occlusion, revealed that the fibrinolytic response was more pronounced in the 20 micrograms EE group. There was also an increase in the threshold of fibrinolytic inhibition (ratio PAI-1) in both groups, which was less pronounced in the 20 micrograms EE group. Apart from isolated measurements, all parameters remained within their normal ranges and values returned to baseline in the follow-up cycle. It is concluded that both preparations had a balanced effect on the hemostatic system stimulating both pro-coagulant and fibrinolytic activity. No statistically significant differences were observed between the two groups; however, there was a trend towards greater fibrinolytic capacity in the 20 micrograms EE group. In Germany, 40 healthy women aged 18-30 with no contraindications to combined oral contraceptives (OCs) participated in a comparative study (2 pre-treatment cycles, 6 treatment cycles, and 1 post-treatment follow-up cycle). It aimed to assess the effect of the new low-dose monophasic OCs containing 20 mcg ethinyl estradiol (EE) and 75 mcg gestodene on the hemostatic system, the effect of reducing the EE dose from 30 mcg to 20 mcg, and the effect of this OC and another combined OC with 30 mcg EE on the fibrinolytic capacity at the vessel wall. Both OCs increased coagulatory and fibrinolytic parameters, except for isolated measurements, which remained within their normal ranges. The effect occurred as early as four days after beginning OC treatment. There was a general trend towards increased change during treatment. Within 14 days after stopping OC treatment, most parameters returned to baseline values. Protein C activity increased somewhat in both groups. Protein S activity was reduced in both groups, but the reduction was less in the 20 mcg EE group than in the 30 mcg EE group. There was a tendency towards greater plasminogen activator activity and lower plasminogen activator inhibitor activity in the 20 mcg EE group than in the 30 mcg EE group, suggesting increased fibrinolytic activity in the 20 mcg EE group. In both groups, an increase in the threshold of fibrinolytic inhibition occurred, but the increase was lower in the 20 mcg EE group. These findings suggest that both OC preparations have a balance effect on hemostasis, stimulating both pro-coagulant, anti-coagulant, and fibrinolytic activity. The 20 mcg EE OC tended to have a greater fibrinolytic activity than the 30 mcg EE OC, however.
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