title: The efficacy and safety of an oral contraceptive containing chlormadinone acetate: results of a pooled analysis of noninterventional trials in adult and adolescent women.
abstract: BACKGROUND
  The study was conducted to assess the contraceptive efficacy, cycle events, dysmenorrhea symptoms and skin complaints of a combined oral contraceptive containing 2 mg chlormadinone acetate/0.03 mg ethinylestradiol (CMA/EE) (Belara®, Grünenthal GmbH, Aachen, Germany) in adolescent and adult women using a conventional- or extended-cycle regimen.
  
  
  METHODS
  Data were pooled from six noninterventional trials with CMA/EE intake over 4-12 cycles.
  
  
  RESULTS
  The data pool contained 62,218 women (345,964 cycles), of whom 60,508 were analyzed (325,937.5 cycles), including 46,335 adults, 13,478 adolescents and 695 age unknown; 1710 retrospective documented patients were excluded from analysis. A total of 85 women became pregnant (including women missing pills) on the conventional-cycle regimen (21+7), giving a practical Pearl index of 0.34 [95% confidence interval (CI) 0.27-0.42]. Within this group (n=85), there were 19 pregnancies associated with regular pill intake, which represent a theoretical Pearl index of 0.08 (95% CI 0.05-0.12) per 100 women-years. Overall, cycle stability, bleeding profile, dysmenorrhea and the incidence of seborrhea/acne improved with CMA/EE, and there was no clinically relevant change in body weight or body mass index. Six venous thromboembolic events were reported, equating to an incidence of 2.4 per 10,000 women-years.
  
  
  CONCLUSIONS
  Chlormadinone acetate/ethinylestradiol is effective and well tolerated in adolescent and adult women.
authors.affiliation: Medical Department, Grünenthal GmbH, Zieglerstrasse 6, Aachen, Germany. georg.schramm@grunenthal.com
authors.forename: Georg A K
authors.initials: GA
authors.lastname: Schramm
authors.forename: Guido
authors.initials: G
authors.lastname: Schrah
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy; D000293:Adolescent; D000328:Adult; D002715:Chlormadinone Acetate / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002986:Clinical Trials as Topic; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage* / Q000009:adverse effects; D004412:Dysmenorrhea / Q000188:drug therapy; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005858:Germany; D006801:Humans; D008597:Menstrual Cycle; D020246:Venous Thrombosis / Q000139:chemically induced; D055815:Young Adult
chemical_list: D003277:Contraceptives, Oral, Combined; C488302:ethinylestradiol-chlormadinone acetate; D002715:Chlormadinone Acetate; D004997:Ethinyl Estradiol