Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis

What Was Tested

This registered phase 4 trial tested Leuprolide for endometriosis.

The hemostatic and inflammatory systems may activate each other.

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.

It had two arms (groups): LNG-IUS (active comparator) and GnRHa (active comparator).

LNG-IUS: levonorgestrel intrauterine system.

GnRHa: leuprolide.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 44 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: obese patients with a body mass index (bmi) ≥30 kg/m2; alcohol or drug users; patients currently wishing to conceive.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

The Leuprolide group and the comparison group ran side by side rather than switching.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2010-02 with completion listed for 2012-09.

It ran at 1 site in Brazil.

What Was Measured

Primary outcome: change from baseline in d-dimer (time frame: baseline and 6 months).

It also tracked 5 secondary outcomes, for example 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 and Change from baseline on antifibrinolytic variables.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 44 people with endometriosis.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, Endometriosis research.