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Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis (SIU-LNG)

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ClinicalTrials.gov Identifier: NCT02158845
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : January 21, 2015
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Carolina Sales Vieira, 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


Condition or disease Intervention/treatment Phase
Endometriosis Drug: LNG-IUS: levonorgestrel intrauterine system Drug: GnRHa: leuprolide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effects of the Levonorgestrel-releasing Intrauterine System Compared With the Leuprolide Acetate in Patients With Endometriosis: a Randomized Trial
Study Start Date : February 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Active Comparator: LNG-IUS
LNG-IUS: levonorgestrel intrauterine system
Drug: 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
Other Name: Mirena

Active Comparator: GnRHa
GnRHa: leuprolide
Drug: GnRHa: leuprolide
3.75 mg leuprolide injected intramuscularly on a monthly basis
Other Name: Lupron




Primary Outcome Measures :
  1. change from baseline in d-dimer [ Time Frame: 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 :
  1. change from baseline in Coagulation times [ Time Frame: 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)

  2. change from baseline in procoagulatory variables [ Time Frame: 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.

  3. Change from baseline in natural anticoagulants [ Time Frame: 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.

  4. Change in activation of the coagulation cascade markers [ Time Frame: 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.

  5. Change from baseline on antifibrinolytic variables [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158845


Locations
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Brazil
Hospital das Clinica de Ribeirao Preto
Ribeirão Preto, SP, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: CAROLINA S VIEIRA, MD, PhD Sao Paulo University

Publications of Results:
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Responsible Party: Carolina Sales Vieira, Medical Doctor, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02158845     History of Changes
Other Study ID Numbers: SIU-LNG 001
First Posted: June 9, 2014    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Carolina Sales Vieira, University of Sao Paulo:
endometriosis
blood coagulation
levonorgestrel
GnRH agonist
progesterone-releasing intrauterine device

Additional relevant MeSH terms:
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Levonorgestrel
Endometriosis
Genital Diseases, Female
Leuprolide
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Fertility Agents, Female
Fertility Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents