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Plain Language Summary of Publication
21 July 2023

A plain language summary of the long-term relugolix combination therapy study for uterine fibroids

Authors: Ayman Al-Hendy, Andrea S Lukes, Roberta Venturella, Claudio Villarroel, Laura McKain, Yulan Li, Rachel B Wagman, and Elizabeth A StewartAuthor Info & Affiliations
Volume 12, Number 8
https://doi.org/10.57264/cer-2023-0069
PDF

Abstract

What is this summary about?

This is a summary of a research study (known as a clinical trial) called the LIBERTY extension study. The LIBERTY extension study is a long-term study looking at how well a medicine called relugolix combination therapy worked in reducing blood loss during menstrual periods in women with uterine fibroids with heavy menstrual periods. Women were included in the extension study if they finished the 24-week LIBERTY 1 or LIBERTY 2 studies. Heavy menstrual periods were considered to be menstrual blood loss of about one-third of a cup of blood (80 ml) per cycle for two cycles or about two-thirds of a cup of blood (160 ml) during one cycle. The LIBERTY extension study also looked at whether relugolix combination therapy was safe to take for up to 1 year.

What were the results?

Out of 770 total women with uterine fibroids with heavy menstrual bleeding who took part in the LIBERTY 1 and LIBERTY 2 studies, 476 took part in the LIBERTY extension study. From the start of the LIBERTY 1 and LIBERTY 2 studies through the end of the LIBERTY extension:
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163 women took relugolix combination therapy for 52 weeks
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149 women took relugolix alone for 12 weeks followed by relugolix combination therapy for 40 weeks
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164 women took placebo for 24 weeks followed by relugolix combination therapy for 28 weeks
The LIBERTY extension study showed that most women in all three treatment groups responded to relugolix combination therapy by having less bleeding during their menstrual periods, having improved anemia symptoms, and having stable bone mineral loss. Side effects were similar across treatment groups, and the most common side effects were headaches and hot flushes.

What do the results mean?

Women with uterine fibroids with heavy menstrual bleeding taking relugolix combination therapy may have fewer uterine fibroid bleeding symptoms for up to 1 year of treatment.
Clinical Trial Registration: NCT03049735 (ClinicalTrials.gov) (LIBERTY 1)
Clinical Trial Registration: NCT03103087 (ClinicalTrials.gov) (LIBERTY 2)
Clinical Trial Registration: NCT03412890 (ClinicalTrials.gov) (LIBERTY extension study)
This is an abstract of the Plain Language Summary of Publication article.
To read the full Plain Language Summary of this article, click here to view the PDF.
Link to original article here

Acknowledgments

Myovant Sciences GmbH and the authors thank all of the women who took part in these studies and their families, as well as the treating physicians, research nurses, study coordinators, and operations staff. The authors also thank Dr Alfred N Poindexter, III for his contributions to the original article.

Financial & competing interests disclosure

Disclosure forms provided by the authors are available with the full text in the Obstetrics & Gynecology article.
Writing support for this summary was provided by Kandyss Najjar, PhD, at ICON (Blue Bell, PA) and was funded by Myovant Sciences in partnership with Pfizer Inc.

Open access

This work is licensed under the Creative Commons Attribution 4.0 License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/
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