Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis

Phase 4

Completed

• Conditions: Endometriosis

• Registration Number: NCT02158845
• Lead Sponsor: University of Sao Paulo

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2014-05-31
• Study First Submitted QC: 2014-06-05
• Study First Posted: 2014-06-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-17
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change from baseline in d-dimer	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 Outcome Measures

Name	Time	Method
change from baseline in Coagulation times	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)
change from baseline in procoagulatory variables	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.
Change from baseline in natural anticoagulants	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.
Change in activation of the coagulation cascade markers	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.
Change from baseline on antifibrinolytic variables	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.

Trial Locations

Locations (1)

Hospital das Clinica de Ribeirao Preto; 🇧🇷 Ribeirão Preto, SP, Brazil