title: A 1-year study to compare the hemostatic effects of oral contraceptive containing 20 microg of ethinylestradiol and 100 microg of levonorgestrel with 30 microg of ethinylestradiol and 100 microg of levonorgestrel.
abstract: OBJECTIVE
  To comparatively evaluate the impact of a balanced one-third dose-reduced oral contraceptive on hemostatic variables.
  
  
  METHODS
  In an open-label, randomized study, a dose-reduced oral contraceptive containing 20 microg of ethinylestradiol (EE) and 100 microg of levonorgestrel (LNG) was compared with a reference preparation containing 30 microg of EE and 150 microg of LNG. One-year data were obtained from 48 volunteers.
  
  
  RESULTS
  The direction and magnitude of the changes (increase or decrease) in most of the hemostatic variables were similar in both treatment groups. The majority of changes of all investigated variables remained within the reference ranges of variation. The procoagulatory variables increased to some extent from baseline to treatment cycle 13, while the anticoagulatory variables slightly decreased. In particular, thrombin turnover measured by prothrombin fragments 1+2 increased during treatment by 35% in the 20 microg of EE group and by 38% in the 30 microg of EE group. Statistically significant differences between the two treatment groups were found only for TAT. For the profibrinolytic variables, plasminogen was increased by 42% (20 microg of EE) and 49% (30 microg of EE). While the plasma levels of tPA antigen were reduced during treatment, the levels of its activity were increased by 54% (20 microg of EE) and 20% (30 microg of EE). For PAI, both antigen and activity were decreased, somewhat more pronounced with 20 microg of EE. D-Dimer remained virtually unchanged. Finally, the median FbDP levels were elevated by 30% (20 microg of EE) and 38% (30 microg of EE).
authors: Department of Clinical Biochemistry, Ribe County Hospital and Department for Thrombosis Research, University of Southern Denmark, DK-6700 Esbjerg, Denmark.
authors: Jørgen
authors: J
authors: Jespersen
authors: Jan
authors: J
authors: Endrikat
authors: Bernd
authors: B
authors: Düsterberg
authors: Werner
authors: W
authors: Schmidt
authors: Christoph
authors: C
authors: Gerlinger
authors: Jens
authors: J
authors: Wessel
authors: Johannes J
authors: JJ
authors: Sidelmann
authors: Sven O
authors: SO
authors: Skouby
mesh_terms: D000328:Adult; D003267:Contraception; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004967:Estrogens / Q000008:administration & dosage* / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006487:Hemostasis / Q000187:drug effects*; D006801:Humans; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies
chemical_list: D003280:Contraceptives, Oral, Synthetic; D004967:Estrogens; D004997:Ethinyl Estradiol; D016912:Levonorgestrel