GnRH-a on Angiogenesis of Endometriosis

What Was Tested

In this not phased trial, researchers set out to test Leuprolide for endometriosis.

Purpose: Neo-angiogenesis is necessary for adhesion and invasiveness of endometriotic lesions in women affected by endometriosis.

VEGF is one of the major components of angiogenesis and is part of the major pathway TF-PAR-2-VEGF that leads to neo-angiogenesis.

It had two arms (groups): GnRH-a + (active comparator) and GnRH-a - (no intervention).

Group A \[GnRHa+\] consisted of 30 women with a mean age of 35.5 years and a mean BMI of 27 kg/m2. Seventeen of them were stage 2 and 13 were stage 3 endometriosis. They received GnRH-a \[leuprolide acetate\] for a period of 3 months prior to surgery, whereas they had not received any hormonal treatment within the 12 months before the surgical procedure.

Group B \[GnRHa-\] consisted of 30 patients with a mean age of 38 years and a mean BMI of 27 kg/m2. Sixteen of them had stage 2 and 14 had stage 3 endometriosis. They did not receive GnRH-a treatment before operation. In addition, no treatment with oral contraceptives or other therapy was administered within 12 months prior to surgery.

The registry classes the interventions as drug.

More on the Plan

The subjects in this study were women of reproductive age.

From September 2015 to December 2022, sixty women with known endometriosis \[stage 2 and 3\], were recruited.

Their mean age was 38 years.

They were nulliparous and had a mean BMI of 27 kg/m2.

Who Took Part

60 actual participants took part.

It was open to women only aged from 32 years up to 42 years.

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

Examples of who could join: Endometriosis \[stage 2 and 3\].

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: women who received any hormonal treatment within the 12 months before the surgical procedure; obesity bmi\>32kg/m2.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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.

Only one side, usually the endometriosis participants, was kept unaware of whether Leuprolide was given.

Those kept unaware of assignments: participant.

It started in 2015-09 with completion listed for 2023-01.

It ran at 2 sites in Greece (1) and Japan (1).

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): VEGF (time frame: 3 months). Tissue factor (time frame: 3 months). PAR-2 (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Leuprolide in 60 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.