Efficacy and safety of ASP1707 for endometriosis-associated pelvic pain: the phase II randomized controlled TERRA study

What Was Tested

Researchers studied Leuprolide in the context of endometriosis in this randomized controlled trial publication.

This study was not powered for pairwise comparison of each ASP1707 group versus placebo.

At the time that the TERRA study was conducted, he served as Principal Investigator in his role as Coordinator of the Leuven University Fertility Center.

Who Took Part

According to the abstract, 540 women were involved.

By PubMed's age tags, the people studied were teenagers, young adults, adults and middle-aged adults, women only.

This was a Phase II, multicenter, double-blind, randomized, parallel-group, placebo-controlled study conducted in 540 women from 04 December 2012 to 30 July 2015 in Europe and Japan.

One subject signed informed consent on 04 December 2012; the first subject was randomized on 16 April 2013.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled, multicenter and parallel-group.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the women nor the staff measuring them knew who was on Leuprolide, so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Leuprolide could be set against what happens without it.

More than one site took part, so the women came from several places.

What Was Measured

The subject headings attached to it are Endometriosis, Hormone Antagonists, Imidazoles, Leuprolide, Pain Measurement, Pelvic Pain and Receptors, LHRH.

Author keywords: GnRH antagonists, TERRA and dysmenorrhea.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Leuprolide in 540 women in people with endometriosis.

With several hundred people or more, it is a fairly large study for this kind of research.

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2019 (Human reproduction (Oxford, England)), a journal based in England.

More context: the Leuprolide compound page, Endometriosis research.