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Abstract
Forty healthy female volunteers aged between 19 and 35 years (27.3 ± 4.1 years) with
normal menstrual cycles were included in a double-blind, randomized, placebo-controlled
study to investigate the influence on the hemostatic system of an oral contraceptive
containing 30 μg ethinyl estradiol in combination with 2.00 mg dienogest, which is
a 19-norprogestin without a 17α-ethinyl group. At baseline and during one treatment
cycle, 12 hemostatic parameters were measured on cycle days 7, 14, and 21. The hemostatic
parameters were categorized as either procoagulatory, anticoagulatory and profibrinolytic,
or antifibrinolytic and indicative of fibrin turnover. Differences between placebo
and 30 μg ethinyl estradiol and 2.00 mg dienogest of plasma levels of hemostatic parameters
on cycle days 21 of the precycle and treatment cycle were chosen as target variables.
Prothrombin fragment 1 + 2 (F 1 + 2) was chosen as the main target variable. Equivalence
of F 1 + 2 between placebo and active treatment was noted. Among the procoagulatory
factors, only factor VII activity was found to be increased over placebo in the active
treatment group, but decreased in the placebo group. Protein C activity increased
during the treatment with 30 μg ethinyl estradiol and 2.00 mg dienogest, and was higher
than that of the placebo group in which this parameter decreased during the treatment
cycle. There was a corresponding increase in fibrinolytic activity being reflected
by higher plasminogen levels in the active treatment group in comparison with placebo.
An increase was noted for the fibrinolytic parameter d-dimer. Apart from isolated measurements, the parameters remained in their respective
normal ranges. The data combine to suggest that 30 μg ethinyl estradiol and 2.00 mg
dienogest has a balanced effect on the hemostatic system stimulating both procoagulatory
and fibrinolytic activity.
Keywords
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Article info
Publication history
Accepted:
May 19,
1997
Received in revised form:
May 19,
1997
Received:
March 10,
1997
Identification
Copyright
© 1997 Published by Elsevier Inc.
