Relugolix combo reduces dysmenorrhea, NMPP in premenopausal women

The use of relugolix 40 mg in combination with oestradiol 1 mg and norethisterone acetate 0.5 mg (relugolix combination therapy [relugolix-CT]) significantly reduced dysmenorrhea and nonmenstrual pelvic pain (NMPP) in premenopausal women with endometriosis who received prior hormonal treatment, according to a post hoc analysis of two phase III trials presented at ESHRE 2023.

“ESHRE recommends hormonal contraceptives or progestins as first-line therapy for endometriosis; however, these treatments may not be efficacious for all women,” said Professor Christian Becker from the Nuffield Department of Women’s and Reproductive Health in Oxford, UK, who presented the study.

Using the pooled SPIRIT 1 (n=638) and SPIRIT 2 (n=623) data, the researchers identified 392 premenopausal women (mean age 34 years) with endometriosis-associated pain who had prior first-line hormonal treatment (eg, oral contraceptives and/or progestogens) before entering the trial. These women were previously randomized to either relugolix-CT (n=121) or placebo (n=134) for 24 weeks. [ESHRE 2023, abstract O-032]

At week 24, a significantly higher proportion of women treated with relugolix-CT compared with placebo achieved a ≥2.8-point reduction in the Numerical Rating Scale (NRS) score for dysmenorrhoea (70.2 percent vs 27.6 percent; difference, 42.6 percent; p<0.0001).

Significantly more relugolix-CT recipients also achieved a ≥2.1-point reduction in the NRS score for NMPP than the placebo recipients at week 24 (60.3 percent vs 40.3 percent; difference, 20.0 percent; p=0.0013).

Mean NRS scores decreased from 7.2 to 1.7 for dysmenorrhoea and from 5.6 to 2.8 for NMPP at week 24 in the relugolix-CT group, representing 78- and 50-percent reduction from baseline in the relugolix group vs the placebo group (p<0.0001 and p=0.0097, respectively).

Significantly more women in the relugolix-CT group were also analgesia-free at week 24 than those in the placebo group (48.8 percent vs 18.7 percent; p<0.0001).

“All findings were comparable to the overall SPIRIT 1 and 2 population, confirming an effective management of endometriosis-associated pain with relugolix-CT in women who previously received hormonal treatment,” said Becker.

“In the US, relugolix-CT has already been approved for the management of moderate-to-severe pain associated with endometriosis,” Becker added.