Relugolix, a novel oral gonadotropin-releasing hormone antagonist, in the treatment of pain symptoms associated with uterine fibroids: a randomized, placebo-controlled, phase 3 study in Japanese women
This first randomized study in premenopausal women with uterine fibroid–associated pain showed that oral once-daily treatment with 40 mg relugolix significantly reduced pain symptoms and was well tolerated.
Volume 112, Issue 5, Pages 922–929.e2
Authors:
Yutaka Osuga, M.D., Ph.D., Kazuaki Enya, M.Pharm., Kentarou Kudou, M.Sc., Hiroshi Hoshiai, M.D., Ph.D.
Abstract:
Objective
To investigate the efficacy and safety of the oral gonadotropin-releasing hormone receptor antagonist, relugolix, in patients experiencing uterine fibroid–associated pain.
Design
Phase 3, multicenter, randomized, double-blind, placebo-controlled study.
Setting
Centers.
Patient(s)
Premenopausal Japanese women (N = 65) experiencing moderate-to-severe uterine fibroid–associated pain with a maximum Numerical Rating Scale (NRS) score of ≥4 were randomized and completed the study.
Intervention(s)
Once-daily 40 mg relugolix (n = 33) or placebo (n = 32) for 12 weeks.
Main Outcome Measure(s)
Primary end point: proportion of patients with a maximum NRS score of ≤1 during the 28-day period before the final dose of study drug. Secondary end points: proportion of patients with no pain (NRS = 0) and percentage of days without pain during the 28-day period before the final dose of study drug; adverse events.
Result(s)
More patients receiving relugolix versus placebo achieved a maximum NRS score of ≤1 during the 28-day period before the final dose of study drug (57.6% vs. 3.1%). Similarly, more patients receiving relugolix versus placebo achieved a maximum NRS score of 0 (48.5% vs. 3.1%) and experienced more days without pain (96.4% vs. 71.4%). More patients receiving relugolix versus placebo experienced treatment-emergent adverse events (TEAEs; 87.9% vs. 56.3%); however, the rate of treatment discontinuation was low and not different between groups. Most TEAEs were mild to moderate in intensity. TEAEs (≥10%) included hot flush, metrorrhagia, hyperhidrosis, and menorrhagia, consistent with relugolix's mechanism of action, and viral upper respiratory tract infection.
Conclusion(s)
Relugolix improved uterine fibroid–associated pain and was well tolerated.
Clinical Trial Registration Numbers
ClinicalTrials.gov: NCT02655224; JAPIC Clinical Trial Information: JapicCTI-163127.
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