title: Comparison of the hemostatic effects of a levonorgestrel-releasing intrauterine system and leuprolide acetate in women with endometriosis: a randomized clinical trial.
abstract: BACKGROUND
  The hemostatic and inflammatory systems may activate each other. Endometriosis is a chronic inflammatory disease affecting 10% of women. The objective of this study was to compare the hemostatic effects of two treatments widely prescribed to women with endometriosis: the levonorgestrel intrauterine system (LNG-IUS) and the gonadotropin-releasing hormone analog (GnRHa) leuprolide acetate.
  
  
  METHODS
  In this randomized open-label controlled trial, 44 women with endometriosis were randomly allocated to one of two groups: 22 women were assigned to use LNG-IUS and 22 to use GnRHa. The assessed variables were D-dimers, fibrinogen, prothrombin time, activated partial thromboplastin time, coagulation factors (F) II, V, VII, VIII, IX, X, and XI, antithrombin (AT), protein C, free protein S, tissue plasminogen activator (t-PA), α2-antiplasmin, thrombin-antithrombin complex, and prothrombin fragment 1+2. All variables were assessed before treatment and six months after treatment onset.
  
  
  RESULTS
  In the LNG-IUS group, FVIII decreased 10% after six months of use. In the GnRHa group, there was a 6% increase in AT, 29% reduction in D-dimers, and 19% increase in t-PA. The LNG-IUS users exhibited a significantly greater reduction of FVIII than the GnRHa users (LNG-IUS: -6.4 ± 14.3% vs. GnRHa: 4.2 ± 12.3%, p=0.02). The women in the GnRHa group exhibited a greater increase of AT than the LNG-IUS users (LNG-IUS: -0.7 ± 9.5% vs. GnRHa: 6.5 ± 10.1%, p=0.02).
  
  
  CONCLUSIONS
  Both hormonal treatments for endometriosis exhibited no association with a procoagulant profile.
authors.affiliation: Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil, Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre - Ribeirão Preto, SP, CEP: 14049-900, Brazil.
authors.forename: Erciliene M M
authors.initials: EM
authors.lastname: Yamaguti
authors.affiliation: Bahiana School of Medicine and Public Health, Av. D. João VI, 275 - Brotas, Salvador - BA, CEP: 40285-001, Brazil.
authors.forename: Milena B
authors.initials: MB
authors.lastname: Brito
authors.affiliation: Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil, Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre - Ribeirão Preto, SP, CEP: 14049-900, Brazil; National Institute of Hormones and Women's Health, Ribeirao Preto, SP, CEP: 14049-900, Brazil.
authors.forename: Rui A
authors.initials: RA
authors.lastname: Ferriani
authors.affiliation: Hemostasis Division, Medical School of Ribeirao Preto, University of São Paulo, Brazil, Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre - Ribeirao Preto, SP, CEP: 14049-900, Brazil.
authors.forename: Andréa A
authors.initials: AA
authors.lastname: Garcia
authors.affiliation: Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil, Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre - Ribeirão Preto, SP, CEP: 14049-900, Brazil; National Institute of Hormones and Women's Health, Ribeirao Preto, SP, CEP: 14049-900, Brazil.
authors.forename: Júlio C
authors.initials: JC
authors.lastname: Rosa-e-Silva
authors.affiliation: Department of Gynecology and Obstetrics, Medical School of Ribeirao Preto, University of São Paulo, Brazil, Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre - Ribeirão Preto, SP, CEP: 14049-900, Brazil; National Institute of Hormones and Women's Health, Ribeirao Preto, SP, CEP: 14049-900, Brazil. Electronic address: carol.sales@usp.br.
authors.forename: Carolina S
authors.initials: CS
authors.lastname: Vieira
mesh_terms: D000293:Adolescent; D000328:Adult; D001777:Blood Coagulation / Q000187:drug effects*; D003271:Contraceptive Agents, Female / Q000008:administration & dosage; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004715:Endometriosis / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology*; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage; D006487:Hemostasis / Q000187:drug effects*; D006490:Hemostatics / Q000008:administration & dosage; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage*; D016912:Levonorgestrel / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003271:Contraceptive Agents, Female; D003692:Delayed-Action Preparations; D005300:Fertility Agents, Female; D006490:Hemostatics; D016912:Levonorgestrel; D016729:Leuprolide
keywords: Blood coagulation; Endometriosis; GnRH agonist; Levonorgestrel; Progesterone-releasing intrauterine device