drugset / Trial / NCT02158845
Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis
Phase 4
Completed
44 enrolled
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico · collabFundação de Amparo à Pesquisa do Estado de São Paulo · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Leuprolide | Other / unclassified | 3.75 mg | Intramuscular |
| Comparator | Levonorgestrel | Small molecule | 20 ug | Other |