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Completed

NCT Number: NCT02158845

Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis

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

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Key information

Conditions

Endometriosis Cardiovascular Diseases Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Thrombosis Urogenital Diseases Vascular Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital das Clinica de Ribeirao Preto

Ribeirão Preto, São Paulo, 14049-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LNG-IUS: levonorgestrel intrauterine system

Drug

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

Other names: Mirena

GnRHa: leuprolide

Drug

3.75 mg leuprolide injected intramuscularly on a monthly basis

Other names: Lupron

Primary outcomes

  1. change from baseline in d-dimer

    Time frame: baseline and 6 months

    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.

Secondary outcomes

  1. change from baseline in Coagulation times

    Time frame: baseline and 6 months

    To compare the change over 6 months (6 months - baseline) of coagulation times as a composite measure of 3 variables: Thrombin time (TT), activated partial thromboplastin time (APTT), and prothrombin time (PT)

  2. change from baseline in procoagulatory variables

    Time frame: baseline and 6 months

    to compare the change over 6 months (6 months - baseline) on procoagulatory variables (Fibrinogen, coagulation factors II, V, VII, VIII, IX, X, and XI) of two treatments widely prescribed to women with endometriosis, LNG-IUS and GnRHa leuprolide acetate.

  3. Change from baseline in natural anticoagulants

    Time frame: baseline and 6 months

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

  4. Change in activation of the coagulation cascade markers

    Time frame: baseline and 6 months

    to compare the change over 6 months (6 months - baseline) on activation of the coagulation cascade markers (concentrations of the thrombin-antithrombin complex and prothrombin fragment 1+2) of two treatments widely prescribed to women with endometriosis, LNG-IUS and GnRHa leuprolide acetate.

  5. Change from baseline on antifibrinolytic variables

    Time frame: Baseline and 6 months

    to compare the change over 6 months (6 months - baseline) on antifibrinolytic variables (Plasminogen activator inhibitor 1, α-2 antiplasmin) of two treatments widely prescribed to women with endometriosis, LNG-IUS and GnRHa leuprolide acetate.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Effects of the Levonorgestrel-releasing Intrauterine System Compared With the Leuprolide Acetate in Patients With Endometriosis: a Randomized Trial

Acronym: SIU-LNG

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 9, 2014
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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