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In females with endometriosis,
once-daily oral relugolix was found to be noninferior to monthly leuprorelin
injections in reducing pelvic pain over a 24-week treatment period.
A phase 3, randomized, active-controlled study published in Fertility and Sterility demonstrated noninferiority of 40 mg relugolix (gonadotropin-releasing hormone antagonist) when compared to leuprorelin (gonadotropin-releasing hormone agonist) in females with endometriosis-associated pain. Tasuku Harada et al. aimed to examine the safety and effectiveness of relugolix in comparison with leuprorelin (as the active comparator) for the management of endometriosis-linked pelvic pain.
This double-dummy, double-blind, multicenter study enrolled females (age >20 years) with regular menstrual cycles (25–38 days) and suffering from endometriosis or ovarian endometrioma and reporting pelvic pain. Participants were randomly segregated into two groups: (i) Relugolix group: Received oral administration of 40 mg relugolix once a day for twenty-four weeks, and (ii) Leuprorelin group: Received subcutaneous injection of 3.75 or 1.88 mg of leuprorelin every four weeks for twenty-four weeks.
An alteration in the maximum visual analog scale (VAS) score for pelvic pain from the baseline until twenty-eight days prior to therapy end was the major outcome ascertained. Alteration in maximum VAS score, a decline in ovarian endometrioma, and discontinuations from treatment-emergent adverse events (TEAEs) are shown in Table 1:
Headache, hot flush, genital hemorrhage, and metrorrhagia were drug-related TEAEs with an incidence of >10% for both groups. The safety profile of both relugolix and leuprorelin were comparable. However, menses were reported to return earlier in women taking relugolix, a tremendous advantage for females who wish to conceive after therapy. Thus, relugolix exhibits a promising potential of becoming a new therapeutic choice to mitigate pain symptoms linked with endometriosis.
Fertility and Sterility
Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain compared with leuprorelin in Japanese women: a phase 3, randomized, double-blind, noninferiority study
Tasuku Harada et al.
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