Evaluation of the effect of a new oral contraceptive containing estetrol and drospirenone on hemostasis parameters
Copyright © 2020 Elsevier Inc. All rights reserved..
OBJECTIVE: To assess the effect on hemostasis parameters of a new combined oral contraceptive (COC).
STUDY DESIGN: In this randomized, single centre, open-label, exploratory study, healthy women received either 15 mg estetrol/3 mg drospirenone (E4/DRSP) (n = 39), 30 mcg ethinylestradiol/150 mcg levonorgestrel (EE/LNG) (n = 30), or 20 mcg ethinylestradiol/3 mg drospirenone (EE/DRSP) (n = 32) for six 28-day cycles. Blood was collected at baseline, cycle 3, and cycle 6. Median change from baseline was evaluated for procoagulant, anticoagulant, and fibrinolytic parameters, and for sex hormone-binding globulin (SHBG).
RESULTS: Median change of endogenous thrombin potential (ETP) based activated protein C sensitivity resistance (APCr) at cycle 6 was +30% for E4/DRSP, +165% for EE/LNG (p-value <0.05 vs E4/DRSP), and +219% for EE/DRSP (p-value <0.05 vs E4/DRSP). Changes to prothrombin fragment 1 + 2 and SHBG for E4/DRSP, EE/LNG, and EE/DRSP were +23%, +71%, and +64% (p-value <0.05 vs E4/DRSP); and +55%, +74% and +251% (p-value <0.05 vs E4/DRSP), respectively. At cycle 6, changes to other hemostasis parameters for E4/DRSP were similar or smaller than for EE/LNG or EE/DRSP.
CONCLUSIONS: In this study, changes in hemostasis parameters after treatment with 6 cycles of E4/DRSP were smaller or similar to those observed for EE/LNG. Similar, but more pronounced changes were also observed versus EE/DRSP, which supports the hypothesis that the effect of COCs on hemostasis parameters is mainly mediated by the estrogenic component. Further studies are needed to provide more insight into the venous thromboembolic risk of E4/DRSP.
IMPLICATIONS STATEMENT: This study reports that the effects on hemostasis parameters of a COC containing 15 mg E4/3 mg DRSP are less or similar to those for EE/LNG or EE/DRSP. It also demonstrates that the choice of estrogen modulates the effects of COCs on hemostasis parameters.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:102 |
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| Enthalten in: |
Contraception - 102(2020), 6 vom: 01. Dez., Seite 396-402 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Douxfils, Jonathan [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 23.09.2021 Date Revised 23.09.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.contraception.2020.08.015 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 100 | 1 | |a Douxfils, Jonathan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Evaluation of the effect of a new oral contraceptive containing estetrol and drospirenone on hemostasis parameters |
| 264 | 1 | |c 2020 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Completed 23.09.2021 | ||
| 500 | |a Date Revised 23.09.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2020 Elsevier Inc. All rights reserved. | ||
| 520 | |a OBJECTIVE: To assess the effect on hemostasis parameters of a new combined oral contraceptive (COC) | ||
| 520 | |a STUDY DESIGN: In this randomized, single centre, open-label, exploratory study, healthy women received either 15 mg estetrol/3 mg drospirenone (E4/DRSP) (n = 39), 30 mcg ethinylestradiol/150 mcg levonorgestrel (EE/LNG) (n = 30), or 20 mcg ethinylestradiol/3 mg drospirenone (EE/DRSP) (n = 32) for six 28-day cycles. Blood was collected at baseline, cycle 3, and cycle 6. Median change from baseline was evaluated for procoagulant, anticoagulant, and fibrinolytic parameters, and for sex hormone-binding globulin (SHBG) | ||
| 520 | |a RESULTS: Median change of endogenous thrombin potential (ETP) based activated protein C sensitivity resistance (APCr) at cycle 6 was +30% for E4/DRSP, +165% for EE/LNG (p-value <0.05 vs E4/DRSP), and +219% for EE/DRSP (p-value <0.05 vs E4/DRSP). Changes to prothrombin fragment 1 + 2 and SHBG for E4/DRSP, EE/LNG, and EE/DRSP were +23%, +71%, and +64% (p-value <0.05 vs E4/DRSP); and +55%, +74% and +251% (p-value <0.05 vs E4/DRSP), respectively. At cycle 6, changes to other hemostasis parameters for E4/DRSP were similar or smaller than for EE/LNG or EE/DRSP | ||
| 520 | |a CONCLUSIONS: In this study, changes in hemostasis parameters after treatment with 6 cycles of E4/DRSP were smaller or similar to those observed for EE/LNG. Similar, but more pronounced changes were also observed versus EE/DRSP, which supports the hypothesis that the effect of COCs on hemostasis parameters is mainly mediated by the estrogenic component. Further studies are needed to provide more insight into the venous thromboembolic risk of E4/DRSP | ||
| 520 | |a IMPLICATIONS STATEMENT: This study reports that the effects on hemostasis parameters of a COC containing 15 mg E4/3 mg DRSP are less or similar to those for EE/LNG or EE/DRSP. It also demonstrates that the choice of estrogen modulates the effects of COCs on hemostasis parameters | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Activated protein C resistance | |
| 650 | 4 | |a Contraception | |
| 650 | 4 | |a Drospirenone | |
| 650 | 4 | |a Estetrol | |
| 650 | 4 | |a Ethinylestradiol | |
| 650 | 4 | |a Hemostasis | |
| 650 | 4 | |a Levonorgestrel | |
| 650 | 7 | |a Androstenes |2 NLM | |
| 650 | 7 | |a Contraceptives, Oral, Combined |2 NLM | |
| 650 | 7 | |a Estrogens |2 NLM | |
| 650 | 7 | |a Sex Hormone-Binding Globulin |2 NLM | |
| 650 | 7 | |a Ethinyl Estradiol |2 NLM | |
| 650 | 7 | |a 423D2T571U |2 NLM | |
| 650 | 7 | |a Estetrol |2 NLM | |
| 650 | 7 | |a ENB39R14VF |2 NLM | |
| 650 | 7 | |a drospirenone |2 NLM | |
| 650 | 7 | |a N295J34A25 |2 NLM | |
| 700 | 1 | |a Klipping, Christine |e verfasserin |4 aut | |
| 700 | 1 | |a Duijkers, Ingrid |e verfasserin |4 aut | |
| 700 | 1 | |a Kinet, Virginie |e verfasserin |4 aut | |
| 700 | 1 | |a Mawet, Marie |e verfasserin |4 aut | |
| 700 | 1 | |a Maillard, Catherine |e verfasserin |4 aut | |
| 700 | 1 | |a Jost, Maud |e verfasserin |4 aut | |
| 700 | 1 | |a Rosing, Jan |e verfasserin |4 aut | |
| 700 | 1 | |a Foidart, Jean-Michel |e verfasserin |4 aut | |
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