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Hemostatic effects of a novel estradiol-based oral contraceptive: an open-label, randomized, crossover study of estradiol valerate/dienogest versus ethinylestradiol/levonorgestrel.


ABSTRACT: A novel estradiol-based combined oral contraceptive (COC) is currently available in many countries worldwide, including Europe and the US. Based on previous studies, it is expected that this estradiol-based COC will have a reduced hepatic effect compared with COCs containing ethinylestradiol with regard to proteins controlling the hemostatic balance.The aim of this study was to compare the hemostatic effects of the estradiol valerate/dienogest COC with a monophasic low-estrogen dose COC containing ethinylestradiol/levonorgestrel.Healthy women aged 18-50 years were randomized to receive a COC containing estradiol valerate/dienogest (2 days estradiol valerate 3?mg, 5 days estradiol valerate 2?mg/dienogest 2?mg, 17 days estradiol valerate 2?mg/dienogest 3?mg, 2 days estradiol valerate 1?mg, 2 days placebo) or ethinylestradiol 0.03?mg/levonorgestrel 0.15?mg in a crossover study design. Women received each treatment for three cycles, with two washout cycles between treatments. The primary efficacy variables were the intra-individual absolute changes in prothrombin fragment 1?+?2 and D-dimer from baseline to cycle three.Data from 29 women were assessed. Intra-individual absolute changes in prothrombin fragment 1?+?2 and D-dimer from baseline to cycle three were less pronounced with estradiol valerate/dienogest than with ethinylestradiol/levonorgestrel.The novel COC containing estradiol valerate/dienogest had similar or less pronounced effects on hemostatic parameters than ethinylestradiol/levonorgestrel.

SUBMITTER: Klipping C 

PROVIDER: S-EPMC3585947 | biostudies-other | 2011

REPOSITORIES: biostudies-other

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Hemostatic effects of a novel estradiol-based oral contraceptive: an open-label, randomized, crossover study of estradiol valerate/dienogest versus ethinylestradiol/levonorgestrel.

Klipping Christine C   Duijkers Ingrid I   Parke Susanne S   Mellinger Uwe U   Serrani Marco M   Junge Wolfgang W  

Drugs in R&D 20110101 2


<h4>Background</h4>A novel estradiol-based combined oral contraceptive (COC) is currently available in many countries worldwide, including Europe and the US. Based on previous studies, it is expected that this estradiol-based COC will have a reduced hepatic effect compared with COCs containing ethinylestradiol with regard to proteins controlling the hemostatic balance.<h4>Objective</h4>The aim of this study was to compare the hemostatic effects of the estradiol valerate/dienogest COC with a mono  ...[more]

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