title: Drospirenone as estrogen-free pill and hemostasis: coagulatory study results comparing a novel 4 mg formulation in a 24 + 4 cycle with desogestrel 75 μg per day.
abstract: BACKGROUND
  A novel estrogen free contraceptive pill, with drospirenone 4 mg in a dosing regimen of 24 + 4, has been developed with a pearl-index of 0.51 (95% CI 0.1054; 1.4922). The aim of the following study was to determine if 4 mg DRSP has an impact on coagulation factors and thrombotic risks in comparison with desogestrel 75 μg.
  
  
  METHODS
  Thirty-nine patients received 4 mg DRSP 24 + 4 d and 29 desogestrel 75 μg per day continuously during nine complete cycles. Following hemostatic parameters were evaluated: Apc resistance, Antithrombin III, Protein C reactivity, Factor VII, Factor VIII, and d-Dimer.
  
  
  RESULTS
  Factor VII decreased from 1.123 to 1.066 in the DRSP group and from 1.241 to 1.034 in the desogestrel group (p = 0.0088). The difference in change of mean Protein C activity from baseline to endpoint was -0.0332 in the DRSP versus -0.157 in the desogestrel group (p = 0.0249). d-Dimer values dropped in the DRSP group from baseline values of 264.9-215.0 ng/mL, whereas in the desogestrel group there was a rise from 201.4 ng/mL to 281.5 ng/mL.
  
  
  CONCLUSIONS
  DRSP 4 mg was not associated with any meaningful changes on hemostatic parameters, indicating a lack of effect on hemostasis.
authors.affiliation: a Outdoor Department of Gynecology and Obstetrics , Frauenklinik München West , München , Germany.|b Exeltis Germany , Ismaning , Germany.
authors.forename: Pedro Antonio
authors.initials: PA
authors.lastname: Regidor
authors.affiliation: c Chemo Spain , Madrid , Spain , and.
authors.forename: Enrico
authors.initials: E
authors.lastname: Colli
authors.affiliation: d Institut für Medizinische Forschung und Fortbildung , Essen , Germany.
authors.forename: Adolf E
authors.initials: AE
authors.lastname: Schindler
mesh_terms: D000328:Adult; D000736:Androstenes / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D001779:Blood Coagulation Factors / Q000187:drug effects*; D003276:Contraceptives, Oral / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D017135:Desogestrel / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology*; D006487:Hemostasis / Q000187:drug effects*; D006801:Humans; D017063:Outcome Assessment, Health Care
chemical_list: D000736:Androstenes; D001779:Blood Coagulation Factors; D003276:Contraceptives, Oral; D017135:Desogestrel; C035144:drospirenone
keywords: Hormonal contraception; ovary; uterus