drugset / Trial / NCT02158845

Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis

NCT02158845

RandomizedParallel-groupOpen-label

Summary

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

Timeline

Start
2010-02
Primary completion
2012-09
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Leuprolide Other / unclassified 3.75 mg Intramuscular
Comparator Levonorgestrel Small molecule 20 ug Other

Indications