Clinical trial NCT02158845: Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis
Official title: Effects of the Levonorgestrel-releasing Intrauterine System Compared With the Leuprolide Acetate in Patients With Endometriosis: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometriosis
Keywords: endometriosis
blood coagulation
levonorgestrel
GnRH agonist
progesterone-releasing intrauterine device
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-06-09
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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.

Primary outcomes:
measure: change from baseline in d-dimer
timeFrame: baseline and 6 months
Secondary outcomes:
measure: change from baseline in Coagulation times
timeFrame: baseline and 6 months
measure: change from baseline in procoagulatory variables
timeFrame: baseline and 6 months
measure: Change from baseline in natural anticoagulants
timeFrame: baseline and 6 months
measure: Change in activation of the coagulation cascade markers
timeFrame: baseline and 6 months
measure: Change from baseline on antifibrinolytic variables
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinica de Ribeirao Preto
state: SP
Study officials:
affiliation: Sao Paulo University
name: CAROLINA S VIEIRA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yamaguti EM, Brito MB, Ferriani RA, Garcia AA, Rosa-e-Silva JC, Vieira CS. Comparison of the hemostatic effects of a levonorgestrel-releasing intrauterine system and leuprolide acetate in women with endometriosis: a randomized clinical trial. Thromb Res. 2014 Dec;134(6):1193-7. doi: 10.1016/j.thromres.2014.09.014. Epub 2014 Sep 20.