title: 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.
abstract: OBJECTIVE
  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.
authors: FSHS Kuopio, Kuopio, Finland. ulla.agren@merck.com
authors: Ulla M
authors: UM
authors: Ågren
authors: Marjatta
authors: M
authors: Anttila
authors: Kristiina
authors: K
authors: Mäenpää-Liukko
authors: Maija-Liisa
authors: ML
authors: Rantala
authors: Hilkka
authors: H
authors: Rautiainen
authors: Werner F
authors: WF
authors: Sommer
authors: Ellen
authors: E
authors: Mommers
mesh_terms: D000293:Adolescent; D000328:Adult; D002097:C-Reactive Protein / Q000378:metabolism; D050260:Carbohydrate Metabolism / Q000187:drug effects; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003277:Contraceptives, Oral, Combined / Q000494:pharmacology*; D003280:Contraceptives, Oral, Synthetic / Q000494:pharmacology; D004958:Estradiol / Q000494:pharmacology*; D004967:Estrogens / Q000494:pharmacology; D004997:Ethinyl Estradiol / Q000494:pharmacology*; D005260:Female; D006487:Hemostasis / Q000187:drug effects; D006801:Humans; D016912:Levonorgestrel / Q000494:pharmacology*; D008535:Megestrol / Q000494:pharmacology*; D008875:Middle Aged; D009649:Norpregnadienes / Q000494:pharmacology*; D012738:Sex Hormone-Binding Globulin / Q000378:metabolism; D014280:Triglycerides / Q000097:blood; D055815:Young Adult
chemical_list: D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D003277:Contraceptives, Oral, Combined; D003280:Contraceptives, Oral, Synthetic; D004967:Estrogens; D009649:Norpregnadienes; D012738:Sex Hormone-Binding Globulin; D014280:Triglycerides; D004997:Ethinyl Estradiol; D004958:Estradiol; D016912:Levonorgestrel; C038501:nomegestrol acetate; D002097:C-Reactive Protein; D008535:Megestrol