A plain language summary describing changes in pain associated with uterine fibroids among women receiving relugolix combination therapy

What is this summary about?: This is a summary of two research studies (known as clinical trials) called LIBERTY 1 and LIBERTY 2. These studies compared how well a medicine called relugolix combination therapy and placebo worked in reducing heavy menstrual bleeding (periods) in women with uterine fibroids (published in a separate article referenced in the section: Where can readers find more information on these studies?). Researchers also looked at whether women with moderate to severe pain from uterine fibroids saw improvement in their worst pain symptoms after 24 weeks of treatment (results described in the present summary).

What are the key takeaways?: Women with moderate to severe pain from uterine fibroids (menstrual or nonmenstrual pain) took either relugolix combination therapy or placebo (once daily by mouth) for 24 weeks. During the last 5 weeks of treatment, 65% of women taking relugolix combination therapy and 19% of women taking placebo reported having minimal or no menstrual pain. Similarly, 45% of women taking relugolix combination therapy and 22% of women taking placebo reported having minimal or no non-menstrual pain. During the same time period, 71% of the women taking relugolix combination therapy and 40% of women taking placebo reported their worst pain was reduced by about one third compared with the start of the study.

What were the main conclusions reported by the researchers?: Women with moderate to severe pain from uterine fibroids taking relugolix combination therapy were more likely to have minimal or no pain from uterine fibroids after treatment compared with women taking placebo.Clinical Trial Registration: NCT03049735 (LIBERTY 1), NCT03103087 (LIBERTY 2) (ClinicalTrials.gov).