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Cited by 107Reproductive Health and ContraceptionLipoproteins and Cardiovascular HealthEstrogen and related hormone effects

Metabolic and Haemostatic Effects of Estradiol Valerate/Dienogest, a Novel Oral Contraceptive: A Randomized, Open-Label, Single-Centre Study

Junge, Wolfgang, Mellinger, Uwe, Parke, Susanne, Serrani, Marco·2011·Clinical Drug Investigation
DOI 10.2165/11590220-000000000-00000
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Abstract

Background and objective The hormonal components of combined oral contraceptives (COCs) have various metabolic and haemostatic effects. The objective of this study was to compare the metabolic and haemostatic effects of a novel COC comprising estradiol valerate/dienogest (E(2)V/DNG) with ethinylestradiol/levonorgestrel (EE/LNG).Methods In a randomized, open-label study conducted in Germany over seven cycles, healthy women aged 18-50 years received E(2)V/DNG (E(2)V 3 mg on days 1-2, E(2)V 2 mg/DNG 2 mg on days 3-7, E(2)V 2 mg/DNG 3 mg on days 8-24, E(2)V 1 mg on days 25-26, placebo on days 27-28; n = 30) or EE/LNG (EE 0.03 mg/LNG 0.05 mg on days 1-6, EE 0.04 mg/LNG 0.075 mg on days 7-11, EE 0.03 mg/LNG 0.125 mg on days 12-21, placebo on days 22-28; n = 28). The primary variables were the mean intraindividual relative changes from baseline to cycle 7 in high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol levels. Changes in other lipid parameters, haemostatic parameters, sex hormone-binding globulin (SHBG), cortisol-binding globulin (CBG), carbohydrate metabolism parameters, blood pressure and body weight were also assessed.Results Mean ± SD HDL cholesterol increased by 7.9% ± 21.8% with E(2)V/DNG and decreased by 2.3% ± 14.4% with EE/LNG. Mean ± SD LDL cholesterol decreased by 6.5% ± 15.9% with E(2)V/DNG and by 3.0% ± 17.4% with EE/LNG. Mean ± SD prothrombin fragment 1 + 2 and D-dimer levels remained essentially unchanged in the E(2)V/DNG group (-0.6% ± 30.3% and -2.1% ± 43.5%, respectively), but increased in the EE/LNG group (by 117.3% ± 358.0% and 62.9% ± 99.5%, respectively). Changes in other hepatic-induced parameters (SHBG, CBG) and carbohydrate metabolism were generally less pronounced with E(2)V/DNG versus EE/LNG. Body weight and blood pressure remained stable throughout the study in both treatment groups. Both formulations were well tolerated, with no serious adverse events reported.Conclusion E(2)V/DNG had a minimal impact on metabolic and haemostatic parameters, and a more favourable effect than EE/LNG on lipid markers.Trial registration ClinicalTrials.gov Identifier: NCT00185224.

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Authors
Junge, W., Mellinger, U., Parke, S., & Serrani, M.
Affiliations
Bayer (Germany) (DE)
Corresponding author
Parke, Susanne
Venue
Clinical Drug Investigation
Publisher
Springer Science and Business Media LLC
Published
2011-08
Volume
31
Issue
8
Pages
573-584
ISSN
  • 0114-2402 (ISSN-L)
  • 1173-2563
DOI
10.2165/11590220-000000000-00000
OpenAlex
W194649371
Cited by
107
References
44
Citations by year
2026: 7 · 2025: 6 · 2024: 9 · 2023: 7 · 2022: 8 · 2021: 9 · 2020: 6 · 2019: 5 · 2018: 5 · 2017: 8 · 2016: 5 · 2015: 3 · 2014: 10 · 2013: 8 · 2012: 10
FWCI
9.11
Type
journal article
Language
en
Open access
closed
Locations
  • Clinical Drug Investigation (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Estrogen and related hormone effects
Keywords
combined oral contraceptives, lipid metabolism, HDL cholesterol, LDL cholesterol, sex hormone-binding globulin, corticosteroid-binding globulin, carbohydrate metabolism, blood pressure, body weight, prothrombin fragment 1+2, D-dimer, hemostasis
MeSH terms
Adult, Contraceptives, Oral, Combined, Drug Combinations, Estradiol, Ethinyl Estradiol, Female, Glucose Tolerance Test, Hematologic Tests, Hemostasis, Humans, Lipids, Middle Aged, Nandrolone, Thyroid Function Tests, Treatment Outcome, Levonorgestrel, Carbohydrate Metabolism, Young Adult

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