Uterine Leiomyoma Associated Pain Treated Effectively by Relugolix Combination Therapy

A new study in Obstetrics & Gynecology journal points that Relugolix-CT was effective and significantly reduced moderate-to-severe uterine leiomyoma-associated pain with a more pronounced effect on menstrual pain.

The effect of once-daily relugolix combination therapy was assessed in a combination of relugolix-CT: relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg, compared with placebo on moderate-to-severe pain in women with uterine leiomyomas and heavy menstrual bleeding.

A multinational, double-blind, 24-week, randomized, phase 3 studies "LIBERTY 1 and 2" were conducted in premenopausal women with uterine leiomyoma–associated heavy menstrual bleeding. A predefined secondary objective was to determine the effect of Relugolix-CT on moderate-to-severe uterine leiomyoma–associated pain in the pain subpopulation. The key secondary endpoint was defined as the proportion of women achieving minimal-to-no uterine leiomyoma–associated pain at week 24; menstrual and nonmenstrual pain were evaluated in prespecified secondary analyses. Treatment comparisons were performed in the pooled LIBERTY 1 and 2 pain subpopulation using the Cochran-Mantel-Haenszel test stratified by baseline menstrual blood loss volume.

A total of 509 women were randomized from both trials to relugolix-CT or placebo. Of these, 277 (54.4%) met pain subpopulation requirements. With relugolix-CT, 45.2% of women achieved minimal-to-no pain compared with 13.9% with placebo. The proportions of women with minimal-to-no pain during menstrual days and during nonmenstrual days were significantly higher with relugolix-CT 65.0% and 44.6% compared with placebo 19.3% , and 21.6%.

Researchers concluded that over 24 weeks, relugolix-CT significantly reduced moderate-to- severe uterine leiomyoma–associated pain with a more pronounced effect on menstrual pain. These data support that relugolix-CT had clinically meaningful effects on women's experience of uterine leiomyoma–associated pain.