Comparison of the hemostatic effects of a levonorgestrel-releasing intrauterine system and leuprolide acetate in women with endometriosis: A randomized clinical trial

• Published in: Thrombosis research 2014-12, Vol.134 (6), p.1193-1197
• Main Authors: Yamaguti, Erciliene M.M, Brito, Milena B, Ferriani, Rui A, Garcia, Andréa A, Rosa-e-Silva, Júlio C, Vieira, Carolina S
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Blood coagulation; Blood Coagulation - drug effects; Contraceptive Agents, Female - administration & dosage; Delayed-Action Preparations - administration & dosage; Endometriosis; Endometriosis - diagnosis; Endometriosis - drug therapy; Endometriosis - physiopathology; Female; Fertility Agents, Female - administration & dosage; GnRH agonist; Hematology, Oncology and Palliative Medicine; Hemostasis - drug effects; Hemostatics - administration & dosage; Humans; Leuprolide - administration & dosage; Levonorgestrel; Levonorgestrel - administration & dosage; Progesterone-releasing intrauterine device; Treatment Outcome; Young Adult
• ISSN: 0049-3848; 1879-2472
• DOI: 10.1016/j.thromres.2014.09.014

Abstract Introduction 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. Materials and 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). Conclusion Both hormonal treatments for endometriosis exhibited no association with a procoagulant profile.