title: Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in comparison to one containing levonorgestrel and ethinylestradiol on markers of endocrine function.
abstract: OBJECTIVE
  To compare the effects of two monophasic combined oral contraceptives, containing either nomegestrol acetate/17β-oestradiol (NOMAC/E2) or levonorgestrel/ ethinylestradiol (LNG/EE) on endocrine function, androgens, and sex hormone-binding globulin (SHBG).
  
  
  METHODS
  Randomised, open-label, multi-centre trial involving 121 healthy women, aged 18-50 years old. Participants received 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 in markers of adrenal and thyroid function, androgens, and SHBG.
  
  
  RESULTS
  Total cortisol, corticosteroid-binding globulin (CBG), and thyroxine-binding globulin (TBG) increased from baseline in both groups, with significantly greater increases in the LNG/EE group. No relevant changes from baseline or differences between the groups were observed for thyroid-stimulating hormone (TSH) and free thyroxine (T4). Androgens and androgen precursors decreased from baseline in both groups, with significantly greater decreases in the LNG/EE group (except for free testosterone). A greater increase in SHBG was observed with NOMAC/E2 than with LNG/EE.
  
  
  CONCLUSIONS
  NOMAC/E2 has significantly less influence on markers of adrenal and thyroid function and androgens than LNG/EE. The clinical relevance of these findings requires further study.
authors.affiliation: FSHS Kuopio, Kuopio, Finland. ulla.agren@merck.com
authors.forename: Ulla M
authors.initials: UM
authors.lastname: Ågren
authors.forename: Marjatta
authors.initials: M
authors.lastname: Anttila
authors.forename: Kristiina
authors.initials: K
authors.lastname: Mäenpää-Liukko
authors.forename: Maija-Liisa
authors.initials: ML
authors.lastname: Rantala
authors.forename: Hilkka
authors.initials: H
authors.lastname: Rautiainen
authors.forename: Werner F
authors.initials: WF
authors.lastname: Sommer
authors.forename: Ellen
authors.initials: E
authors.lastname: Mommers
mesh_terms: D000293:Adolescent; D000328:Adult; 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; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D016912:Levonorgestrel / Q000494:pharmacology*; D008535:Megestrol / Q000494:pharmacology*; D008875:Middle Aged; D009649:Norpregnadienes / Q000494:pharmacology*; D012738:Sex Hormone-Binding Globulin / Q000378:metabolism; D045165:Testosterone Congeners / Q000097:blood; D056825:Thyroxine-Binding Globulin / Q000378:metabolism; D014156:Transcortin / Q000378:metabolism; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined; D003280:Contraceptives, Oral, Synthetic; D004967:Estrogens; D009649:Norpregnadienes; D012738:Sex Hormone-Binding Globulin; D045165:Testosterone Congeners; D056825:Thyroxine-Binding Globulin; D004997:Ethinyl Estradiol; D004958:Estradiol; D016912:Levonorgestrel; C038501:nomegestrol acetate; D014156:Transcortin; D008535:Megestrol; D006854:Hydrocortisone