Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol compared with one containing levonorgestrel and ethinylestradiol on haemostasis, lipids and carbohydrate metabolism

Ulla M Ågren, Marjatta Anttila, Kristiina Mäenpää-Liukko, Maija-Liisa Rantala, Hilkka Rautiainen, Werner F Sommer, Ellen Mommers, Ulla M Ågren, Marjatta Anttila, Kristiina Mäenpää-Liukko, Maija-Liisa Rantala, Hilkka Rautiainen, Werner F Sommer, Ellen Mommers

Abstract

Objectives: To compare the effects of a combined oral contraceptive (COC) containing nomegestrol acetate and 17β-oestradiol (NOMAC/E2) on haemostasis, lipids, carbohydrate metabolism, C-reactive protein (CRP) and sex hormone-binding globulin (SHBG) with those of a COC containing levonorgestrel and ethinylestradiol (LNG/EE).

Methods: In a randomised, open-label study, 121 healthy women, 18-50 years of age, were randomly assigned to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n=60) or LNG/EE (150 μg/30 μg) in a 21/7-day regimen (n=61) for six cycles. The primary outcome was the change from baseline to cycle 6 for all indices.

Results: All parameters were similar at baseline between the two groups. Over six cycles, NOMAC/E2 had less effect on most haemostatic indices than LNG/EE. Lipids were essentially unchanged with NOMAC/E2, whereas with LNG/EE high-density lipoprotein cholesterol decreased and low-density lipoprotein cholesterol and triglycerides slightly increased. NOMAC/E2 induced negligible changes in glucose and insulin parameters, in contrast to LNG/EE. A much smaller increase in CRP was observed with NOMAC/E2 than with LNG/EE. NOMAC/E2 was associated with a greater increase in SHBG.

Conclusions: The monophasic COC NOMAC/E2 had less influence on haemostasis, lipids and carbohydrate metabolism than the COC LNG/EE.

Figures

Figure 1
Figure 1
Disposition of subjects. NOMAC/E2, nomegestrol acetate/17β-oestradiol; LNG/EE, levonorgestrel/ethinylestradiol.
Figure 2
Figure 2
Box whisker plots for NOMAC/E2 and LNG/EE of relative changes from baseline to end of cycle 6 in selected haemostatic and lipid parameters and SHBG. The edges of the boxes present the 25th and 75th sample percentiles (quartiles). The distance between these sample percentiles is the interquartile range. The vertical line in the box shows the median and the whiskers are drawn up to the smallest and largest value within 1.5-times the interquartile range. NOMAC, nomegestrol acetate/17β-oestradiol; LNG, levonorgestrel/ethinylestradiol; APCsr, activated protein C sensitivity ratio; ETP, endogenous thrombin potential; aPTT, activated partial thromboplastin time; HDL-C, high-density lipoprotein cholesterol; LDLC, low-density lipoprotein cholesterol; SHBG, sex hormone-binding globulin.

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