Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Leuprolide; Levonorgestrel

Criteria

Inclusion Criteria:

• to have endometriosis

• aged 18 to 40 years

• Being without contraceptives for at least 3 months or with depot medroxyprogesterone acetate or GnRHa for at least 6 months at the time of randomization.

Exclusion Criteria:

• obese patients with a body mass index (BMI) ≥30 kg/m2

• smokers

• diabetics

• alcohol or drug users

• patients currently wishing to conceive

• patients with chronic diseases (except endometriosis)

• patients with infectious processes

• patients with a personal and/or family history of thromboembolic events

• patients taking medications known to interfere with inflammation markers (such as hormonal and nonhormonal anti-inflammatory agents) within the 15 days before the study.