title: Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen.
abstract: OBJECTIVE
  The primary objective was to assess the efficacy, cycle control and tolerability of a monophasic combined oral contraceptive (COC) containing nomegestrol acetate (NOMAC) and 17β-oestradiol (E2). Effects on acne were evaluated as a secondary objective. Results were compared to those of a COC containing drospirenone (DRSP) and ethinylestradiol (EE).
  
  
  METHODS
  Women (aged 18-50 years) were randomised to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n=1591) or DRSP/EE (3 mg/30 μg) in a 21/7-day regimen (n=535) for 13 cycles.
  
  
  RESULTS
  Estimated Pearl Indices for NOMAC/E2 and DRSP/EE were 0.38 and 0.81 in women aged≤35 years and 0.31 and 0.66 for all women (18-50 years), respectively. Scheduled withdrawal bleedings were shorter and lighter among users of NOMAC/E2 and were sometimes absent altogether. Intracyclic bleeding/spotting was infrequent in both groups, and decreased over time. Type and frequency of adverse events were similar to those typically reported for COCs.
  
  
  CONCLUSIONS
  These data show that NOMAC/E2 provides high contraceptive efficacy with acceptable cycle control as well as an overall adverse event profile similar to that of DRSP/EE.
authors: Sexual Health Services, Newcastle Hospitals Community Health, Newcastle upon Tyne, UK. Diana.Mansour@newcastle-pct.nhs.uk
authors: Diana
authors: D
authors: Mansour
authors: Carole
authors: C
authors: Verhoeven
authors: Werner
authors: W
authors: Sommer
authors: Edith
authors: E
authors: Weisberg
authors: Surasak
authors: S
authors: Taneepanichskul
authors: Gian Benedetto
authors: GB
authors: Melis
authors: Inger
authors: I
authors: Sundström-Poromaa
authors: Tjeerd
authors: T
authors: Korver
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy; D000293:Adolescent; D000328:Adult; D000736:Androstenes / Q000009:adverse effects / Q000627:therapeutic use; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects* / Q000627:therapeutic use*; D003280:Contraceptives, Oral, Synthetic / Q000009:adverse effects / Q000627:therapeutic use; D004958:Estradiol / Q000009:adverse effects / Q000627:therapeutic use; D004967:Estrogens / Q000009:adverse effects / Q000627:therapeutic use; D004997:Ethinyl Estradiol / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008535:Megestrol / Q000009:adverse effects / Q000627:therapeutic use; D008597:Menstrual Cycle / Q000187:drug effects; D008796:Metrorrhagia / Q000139:chemically induced*; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D009649:Norpregnadienes / Q000009:adverse effects / Q000627:therapeutic use; D011247:Pregnancy; D018873:Pregnancy Rate; D013375:Substance Withdrawal Syndrome; D055815:Young Adult
chemical_list: D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D003280:Contraceptives, Oral, Synthetic; D004967:Estrogens; D000451:Mineralocorticoid Receptor Antagonists; D009649:Norpregnadienes; D004997:Ethinyl Estradiol; D004958:Estradiol; C038501:nomegestrol acetate; D008535:Megestrol; C035144:drospirenone