Endometriosis Clinical Trial
Official title:
Effects of the Levonorgestrel-releasing Intrauterine System Compared With the Leuprolide Acetate in Patients With Endometriosis: a Randomized Trial
The hemostatic and inflammatory systems may activate each other. Endometriosis is a chronic
inflammatory disease affecting 10% of women. The objective of this study is 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.
Hypothesis:
H0: There is no alteration in hemostatic system with the use of GnRHa or LNG-IUS H1: There
is alteration in hemostatic system with the use of GnRHa or LNG-IUS
Materials and Methods: In this randomized open-label controlled trial, 44 women with endometriosis will be randomly allocated to one of two groups: 22 women will be assigned to use LNG-IUS and 22 to use GnRHa. The assessed variables will be 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 will be assessed before treatment and six months after treatment onset. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
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