title: Evaluation of efficacy, safety and effects on symptoms of androgenization of a generic oral contraceptive containing chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg.
abstract: BACKGROUND
  This prospective noninterventional study assessed the contraceptive efficacy, safety and the effects on signs of androgenization of the generic oral contraceptive containing 2 mg chlormadinone acetate/0.03 mg ethinylestradiol (CMA/EE) in a real-world setting.
  
  
  METHODS
  A total of 1440 women were investigated during a six-cycle period by 229 gynecological practices throughout Germany.
  
  
  RESULTS
  The adjusted Pearl index was 0.136 (unadjusted: 0.271). Of 463 patients with cycle irregularities at baseline, 83.4% had regular cycles after six cycles. Likewise, 74.1% of 162 patients with spotting or breakthrough bleeding at baseline were free from these symptoms at the end of study. The percentage of patients with dysmenorrhea decreased significantly from baseline (36.5%) to visit 3 after six cycles (12.3%; p=.0001), with a significant reduction in the use of pain medication (p<.0001). Additionally, the number of patients with skin and hair problems was significantly reduced (skin: 56.3% at baseline, 19.6% after six cycles; hair: 45.7% at baseline, 13.4% after six cycles; p=.001). CMA/EE was well tolerated by the patients, and 89.44% of the gynecologists were satisfied with the treatment.
  
  
  CONCLUSIONS
  Generic CMA/EE exhibits very good contraceptive efficacy, cycle control and dysmenorrhea reduction. Furthermore, treatment with generic CMA/EE led to a favorable reduction of skin and hair problems in our study.
authors.affiliation: Philipps-University of Marburg, Department of Gynecological Endocrinology, Reproductive Medicine and Osteoporosis, 35043 Marburg, Germany.
authors.forename: Peyman
authors.initials: P
authors.lastname: Hadji
authors.forename: Jutta
authors.initials: J
authors.lastname: Biskup
authors.forename: Jelena
authors.initials: J
authors.lastname: Boekhoff
authors.forename: May
authors.initials: M
authors.lastname: Ziller
authors.forename: Michael
authors.initials: M
authors.lastname: Bonn
authors.forename: Lucio
authors.initials: L
authors.lastname: Rovati
mesh_terms: D000328:Adult; D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D002715:Chlormadinone Acetate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects / Q000627:therapeutic use; D004338:Drug Combinations; D016568:Drugs, Generic / Q000009:adverse effects / Q000627:therapeutic use*; D004412:Dysmenorrhea / Q000188:drug therapy* / Q000503:physiopathology; D004967:Estrogens / Q000009:adverse effects / Q000627:therapeutic use*; D004997:Ethinyl Estradiol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006201:Hair Diseases / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D010352:Patient Dropouts; D017699:Pelvic Pain / Q000209:etiology / Q000517:prevention & control; D011358:Product Surveillance, Postmarketing; D011372:Progestins / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D012720:Severity of Illness Index; D012871:Skin Diseases / Q000209:etiology / Q000517:prevention & control; D014770:Virilism / Q000188:drug therapy* / Q000503:physiopathology; D055815:Young Adult
chemical_list: D000726:Androgen Antagonists; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D016568:Drugs, Generic; D004967:Estrogens; D011372:Progestins; C488302:ethinylestradiol-chlormadinone acetate; D002715:Chlormadinone Acetate; D004997:Ethinyl Estradiol