title: Effects on bone mineral density of a monophasic combined oral contraceptive containing nomegestrol acetate/17β-estradiol in comparison to levonorgestrel/ethinylestradiol.
abstract: OBJECTIVE
  To compare the effects of a monophasic combined oral contraceptive containing nomegestrol acetate/17β-estradiol (NOMAC/E2) on bone mineral density with a combined oral contraceptive containing levonorgestrel/ethinylestradiol (LNG/EE).
  
  
  METHODS
  Prospective, randomized, open-label, comparative clinical study.
  
  
  METHODS
  Gynecology center in Norway.
  
  
  METHODS
  One hundred and ten women (20-35 years old) actively seeking contraception. Methods. For 26 consecutive 28-day cycles, women received one of the following two treatments: NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n= 56); or LNG/EE (150 μg/30 μg) in a 21/7-day regimen (n= 54). Main outcome measures. Bone mineral density of the lumbar spine, femoral neck, hip and trochanter (measured by dual energy X-ray absorptiometry); associated z-scores of the lumbar spine and femoral neck.
  
  
  RESULTS
  In NOMAC/E2 users, mean (±SD) z-score change from baseline for lumbar spine and femoral neck were 0.019 ± 0.242 and -0.007 ± 0.228, respectively, vs. 0.121 ± 0.269 and 0.044 ± 0.253 in LNG/EE users, respectively. Differences between treatment groups were not significant (p= 0.19 and p= 0.57, respectively). There were no significant differences between changes in hip and trochanter z-scores between NOMAC/E2 and LNG/EE treatments.
  
  
  CONCLUSIONS
  After two years, NOMAC/E2 had no clinically relevant effect on bone mineral density. No significant difference in the effect on bone mineral density between NOMAC/E2 and LNG/EE was observed.
authors: Medicus, Trondheim, Norway. terje@medicus.no
authors: Terje
authors: T
authors: Sørdal
authors: Paul
authors: P
authors: Grob
authors: Carole
authors: C
authors: Verhoeven
mesh_terms: D015502:Absorptiometry, Photon; D000328:Adult; D015519:Bone Density / Q000187:drug effects*; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage*; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage; D004958:Estradiol / Q000008:administration & dosage; D004967:Estrogens / Q000008:administration & dosage; D004997:Ethinyl Estradiol / Q000008:administration & dosage; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage; D008535:Megestrol / Q000008:administration & dosage; D009649:Norpregnadienes / Q000008:administration & dosage; D045167:Progesterone Congeners / Q000008:administration & dosage; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined; D003280:Contraceptives, Oral, Synthetic; D004967:Estrogens; D009649:Norpregnadienes; D045167:Progesterone Congeners; D004997:Ethinyl Estradiol; D004958:Estradiol; D016912:Levonorgestrel; C038501:nomegestrol acetate; D008535:Megestrol