Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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LNG-IUS

LNG-IUS: levonorgestrel intrauterine system

Group Type ACTIVE_COMPARATOR

LNG-IUS: levonorgestrel intrauterine system

Intervention Type DRUG

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

GnRHa

GnRHa: leuprolide

Group Type ACTIVE_COMPARATOR

GnRHa: leuprolide

Intervention Type DRUG

3.75 mg leuprolide injected intramuscularly on a monthly basis

Interventions

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LNG-IUS: levonorgestrel intrauterine system

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

Intervention Type DRUG

GnRHa: leuprolide

3.75 mg leuprolide injected intramuscularly on a monthly basis

Intervention Type DRUG

Other Intervention Names

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Mirena Lupron

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No