Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis

University of Sao Paulo44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Endometriosis

Interventions

LNG-IUS: levonorgestrel intrauterine systemDRUG

LNG-IUS (levonorgestrel intrauterine system) is inserted until the fifth day of the cycle. It releases 20 mcg/day of LNG

GnRHa: leuprolideDRUG

3.75 mg leuprolide injected intramuscularly on a monthly basis

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital das Clinica de Ribeirao Preto

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

change from baseline in d-dimer

to compare the change over 6 months (6 months - baseline) on d-dimer of two treatments widely prescribed to women with endometriosis, LNG-IUS and GnRHa leuprolide acetate.