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Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endometriosis

Intervention: LNG-IUS: levonorgestrel intrauterine system (Drug); GnRHa: leuprolide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Sao Paulo

Official(s) and/or principal investigator(s):
CAROLINA S VIEIRA, MD, PhD, Principal Investigator, Affiliation: Sao Paulo University

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: change from baseline in d-dimer

Secondary outcome:

change from baseline in Coagulation times

change from baseline in procoagulatory variables

Change from baseline in natural anticoagulants

Change in activation of the coagulation cascade markers

Change from baseline on antifibrinolytic variables

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

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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.

Locations and Contacts

Hospital das Clinica de Ribeirao Preto, Ribeirão Preto, SP 14049-900, Brazil
Additional Information

Starting date: February 2010
Last updated: January 17, 2015

Page last updated: August 23, 2015

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