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Clin Drug Investig. 2011;31(8):573-584. doi: 10.2165/11590220-000000000-00000.

Metabolic and haemostatic effects of estradiol valerate/dienogest, a novel oral contraceptive: a randomized, open-label, single-centre study.

Author information

1
Laboratorium fuer Klinische Forschung, Kiel, Germany.
2
Bayer HealthCare Pharmaceuticals, Müllerstraβe 178, 13342, Berlin, Germany.
3
Bayer HealthCare Pharmaceuticals, Müllerstraβe 178, 13342, Berlin, Germany. susanne.parke@bayer.com.

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.

[Indexed for MEDLINE]

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