Trial intelligence / Profile preview

Hemostatic Effects of LNG-IUS vs Leuprolide in Endometriosis

NCT02158845Phase 4

Key facts

Status: Completed
Start: Feb 2010
Primary completion: Sep 2012
Countries: 1
Sponsor: Universidade de São Paulo
Modality: Small Molecules

Drugs: avatrombopag
Conditions: endometriosis

Overview

Phase 4, randomised, open-label trial of avatrombopag in endometriosis (2 arms), sponsored by Universidade de São Paulo. Primary endpoint: Change from baseline in D-dimer at 6 months. Started Feb 2010; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Levonorgestrel Intrauterine System
LNG-IUS releasing 20 mcg/day
Leuprolide Acetate
3.75 mg intramuscular injection monthly

Who it enrols

Women aged 18-40 with endometriosis, excluding those with BMI >= 30, smokers, diabetics, or history of thromboembolic events.

Endpoints

Primary

Change from baseline in D-dimer6 months

Secondary

Change from baseline in Coagulation times6 months
Change from baseline in procoagulatory variables6 months
Change from baseline in natural anticoagulants6 months
Change in activation of the coagulation cascade markers6 months
Change from baseline on antifibrinolytic variables6 months

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