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Clinical Drug Investigation
Published in: Clinical Drug Investigation 8/2011

01-08-2011 | Original Research Article

Metabolic and Haemostatic Effects of Estradiol Valerate/Dienogest, a Novel Oral Contraceptive

A Randomized, Open-Label, Single-Centre Study

Authors: Wolfgang Junge, Uwe Mellinger, Dr Susanne Parke, Marco Serrani

Published in: Clinical Drug Investigation | Issue 8/2011

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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 (E2V/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 E2V/DNG (E2V 3 mg on days 1–2, E2V 2 mg/DNG 2 mg on days 3–7, E2V 2 mg/DNG 3 mg on days 8–24, E2V 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 E2V/DNG and decreased by 2.3%±14.4% with EE/LNG. Mean ± SD LDL cholesterol decreased by 6.5% ±15.9% with E2V/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 E2V/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 arameters (SHBG, CBG) and carbohydrate metabolism were generally less pronounced with E2V/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: E2V/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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Metadata
Title
Metabolic and Haemostatic Effects of Estradiol Valerate/Dienogest, a Novel Oral Contraceptive
A Randomized, Open-Label, Single-Centre Study
Authors
Wolfgang Junge
Uwe Mellinger
Dr Susanne Parke
Marco Serrani
Publication date
01-08-2011
Publisher
Springer International Publishing
Published in
Clinical Drug Investigation / Issue 8/2011
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.2165/11590220-000000000-00000

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