Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis (SIU-LNG)

University of Sao Paulo

Status and phase

Completed

Phase 4

Conditions

Endometriosis

Treatments

Drug: LNG-IUS: levonorgestrel intrauterine system

Drug: GnRHa: leuprolide

Study type

Interventional

Funder types

Other

Identifiers

NCT02158845

SIU-LNG 001

Details and patient eligibility

About

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

Full description

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.

Enrollment

44 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.