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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 C, Duijkers I, Parke S, Mellinger U, Serrani M, Junge W - Drugs R D (2011)

Bottom Line: 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.The novel COC containing estradiol valerate/dienogest had similar or less pronounced effects on hemostatic parameters than ethinylestradiol/levonorgestrel.

View Article: PubMed Central - PubMed

Affiliation: Dinox BV, Groningen, the Netherlands.

ABSTRACT

Background: 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.

Objective: 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.

Study design: 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.

Results: 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.

Conclusion: The novel COC containing estradiol valerate/dienogest had similar or less pronounced effects on hemostatic parameters than ethinylestradiol/levonorgestrel.

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Absolute level at cycle three, intra-individual absolute change and intra-individual change from baseline to cycle three in pro- and anti-coagulatory markers in women (n = 29) during treatment with estradiol valerate/dienogest (E2V/DNG) or ethinylestradiol/levonorgestrel (EE/LNG).[n = 28]
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Tab3: Absolute level at cycle three, intra-individual absolute change and intra-individual change from baseline to cycle three in pro- and anti-coagulatory markers in women (n = 29) during treatment with estradiol valerate/dienogest (E2V/DNG) or ethinylestradiol/levonorgestrel (EE/LNG).[n = 28]

Mentions: Changes in pro-coagulatory markers with treatment were generally less pronounced with estradiol valerate/dienogest than with ethinylestradiol/levonorgestrel (table III). Mean fibrinogen levels were elevated above the normal range in both treatment groups, although the mean intra-individual increase was greater in the ethinylestradiol/levonorgestrel group (table III). Mean levels of factor VII activity increased minimally in the estradiol valerate/dienogest group and slightly more pronounced in the ethinylestradiol/levonorgestrel group; however, mean levels remained within the reference range. Almost no changes in the mean levels of factor VIII were observed in either treatment group (table III).


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

Klipping C, Duijkers I, Parke S, Mellinger U, Serrani M, Junge W - Drugs R D (2011)

Absolute level at cycle three, intra-individual absolute change and intra-individual change from baseline to cycle three in pro- and anti-coagulatory markers in women (n = 29) during treatment with estradiol valerate/dienogest (E2V/DNG) or ethinylestradiol/levonorgestrel (EE/LNG).[n = 28]
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3585947&req=5

Tab3: Absolute level at cycle three, intra-individual absolute change and intra-individual change from baseline to cycle three in pro- and anti-coagulatory markers in women (n = 29) during treatment with estradiol valerate/dienogest (E2V/DNG) or ethinylestradiol/levonorgestrel (EE/LNG).[n = 28]
Mentions: Changes in pro-coagulatory markers with treatment were generally less pronounced with estradiol valerate/dienogest than with ethinylestradiol/levonorgestrel (table III). Mean fibrinogen levels were elevated above the normal range in both treatment groups, although the mean intra-individual increase was greater in the ethinylestradiol/levonorgestrel group (table III). Mean levels of factor VII activity increased minimally in the estradiol valerate/dienogest group and slightly more pronounced in the ethinylestradiol/levonorgestrel group; however, mean levels remained within the reference range. Almost no changes in the mean levels of factor VIII were observed in either treatment group (table III).

Bottom Line: 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.The novel COC containing estradiol valerate/dienogest had similar or less pronounced effects on hemostatic parameters than ethinylestradiol/levonorgestrel.

View Article: PubMed Central - PubMed

Affiliation: Dinox BV, Groningen, the Netherlands.

ABSTRACT

Background: 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.

Objective: 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.

Study design: 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.

Results: 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.

Conclusion: The novel COC containing estradiol valerate/dienogest had similar or less pronounced effects on hemostatic parameters than ethinylestradiol/levonorgestrel.

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