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
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Sponsor:
University of Sao Paulo
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
Tracking Information | ||||
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First Submitted Date ICMJE | May 31, 2014 | |||
First Posted Date ICMJE | June 9, 2014 | |||
Last Update Posted Date | January 21, 2015 | |||
Study Start Date ICMJE | February 2010 | |||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis | |||
Official Title ICMJE | Effects of the Levonorgestrel-releasing Intrauterine System Compared With the Leuprolide Acetate in Patients With Endometriosis: a Randomized Trial | |||
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 |
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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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) |
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Condition ICMJE | Endometriosis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
44 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | September 2012 | |||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 40 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Brazil | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02158845 | |||
Other Study ID Numbers ICMJE | SIU-LNG 001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Carolina Sales Vieira, University of Sao Paulo | |||
Study Sponsor ICMJE | University of Sao Paulo | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Sao Paulo | |||
Verification Date | January 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |