Relugolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in women with endometriosis-associated pain: phase 2 safety and efficacy 24-week results

What Was Tested

This randomized controlled trial paper looks at Leuprolide in the context of endometriosis.

The aim of this study was to evaluate safety of relugolix over 24 weeks in women with endometriosis-associated pain.

Why It Was Studied

Relugolix is a once-daily, oral, nonpeptide, gonadotropin-releasing hormone receptor antagonist.

Who Took Part

According to the abstract, 24 women were involved.

PubMed tags the participants as women only.

The primary outcome was safety, including bone mineral density (BMD) and treatment-emergent adverse events (TEAEs).

Analysis sets were defined as all patients who were administered the study drug.

How the Study Was Run

In design terms this was a randomized, double-blind, open-label, placebo-controlled and parallel-group study.

The women were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

As a double-blind Leuprolide study, the assignments were hidden from both participants and investigators until the end.

Nothing was hidden in this open-label Leuprolide study: the women and staff both knew the treatment.

Some women received a placebo instead of Leuprolide, giving a reference point.

This phase 2, randomized, open-label, parallel-group extension study was conducted in 101 clinics in Japan.

Relugolix was administered orally once daily, and leuprorelin subcutaneously once every 4 weeks.

Secondary endpoints included visual analog scale (VAS) scores for endometriosis-associated pain.

What Was Measured

Topics PubMed links to this paper include Endometriosis, Japan, Leuprolide, Pelvic Pain, Phenylurea Compounds and Pyrimidinones.

Author keywords: Extension study, Gonadotropin-releasing hormone antagonist, Leuprorelin acetate and Relugolix.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Leuprolide in 24 women in people with endometriosis.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Results are reported in around 10 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2021 (BMC women's health), a journal based in England.

More context: the Leuprolide compound page, Endometriosis research.