NCT02158845

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

2.6 years

First QC Date

May 31, 2014

Last Update Submit

January 17, 2015

Conditions

Endometriosis

Keywords

endometriosisblood coagulationlevonorgestrelGnRH agonistprogesterone-releasing intrauterine device

Outcome Measures

Primary Outcomes (1)

  • change from baseline in d-dimer

    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.

    baseline and 6 months

Secondary Outcomes (5)

  • change from baseline in Coagulation times

    baseline and 6 months

  • change from baseline in procoagulatory variables

    baseline and 6 months

  • Change from baseline in natural anticoagulants

    baseline and 6 months

  • Change in activation of the coagulation cascade markers

    baseline and 6 months

  • Change from baseline on antifibrinolytic variables

    Baseline and 6 months

Study Arms (2)

LNG-IUS

ACTIVE COMPARATOR

LNG-IUS: levonorgestrel intrauterine system

Drug: LNG-IUS: levonorgestrel intrauterine system

GnRHa

ACTIVE COMPARATOR

GnRHa: leuprolide

Drug: GnRHa: leuprolide

Interventions

LNG-IUS: levonorgestrel intrauterine systemDRUG

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

Also known as: Mirena
LNG-IUS
GnRHa: leuprolideDRUG

3.75 mg leuprolide injected intramuscularly on a monthly basis

Also known as: Lupron
GnRHa

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinica de Ribeirao Preto

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 25283586RESULT

MeSH Terms

Conditions

EndometriosisThrombosis

Interventions

LevonorgestrelLeuprolide

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsGonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • CAROLINA S VIEIRA, MD, PhD

    Sao Paulo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, PhD

Study Record Dates

First Submitted

May 31, 2014

First Posted

June 9, 2014

Study Start

February 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

BR(1)