Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose–response manner: a randomized, double-blind, placebo-controlled study

亮丙瑞林 医学 安慰剂 子宫内膜异位症 盆腔疼痛 可视模拟标度 曲普瑞林 不利影响 安慰剂对照研究 随机对照试验 泌尿科 内科学 麻醉 促黄体激素 促性腺激素释放激素 外科 激素 双盲 病理 替代医学
作者
Yutaka Osuga,Yoshifumi Seki,Masataka Tanimoto,Takeru Kusumoto,Kentarou Kudou,Naoki Terakawa
出处
期刊:Fertility and Sterility [Elsevier BV]
卷期号:115 (2): 397-405 被引量:58
标识
DOI:10.1016/j.fertnstert.2020.07.055
摘要

ObjectiveTo evaluate the efficacy and safety of three dose levels of relugolix, a gonadotropin-releasing hormone receptor antagonist, compared with placebo and leuprorelin in women with endometriosis-associated pain.DesignPhase 2, multicenter, randomized, double-blind, placebo-controlled study.SettingHospitals and clinics.Patient(s)Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain.Intervention(s)During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection.Main Outcome Measure(s)Primary endpoint was the change from baseline in mean visual analog scale score for pelvic pain during 28 days before the end of treatment.Result(s)The mean changes in mean visual analog scale score for pelvic pain were –3.8 mm in the placebo group; –6.2, –8.1, and –10.4 mm in the relugolix 10-mg, 20-mg, and 40-mg groups; respectively; and –10.6 mm in the leuprorelin group. The major adverse events with relugolix were hot flush, metrorrhagia, menorrhagia, and irregular menstruation, and bone mineral density decrease in a dose–response manner, which were also observed in the leuprorelin group with a frequency comparable with that in the relugolix 40-mg group.Conclusion(s)Oral administration of relugolix alleviated endometriosis-associated pain in a dose–response manner and was generally well tolerated. Relugolix 40 mg demonstrated efficacy and safety comparable with those of leuprorelin.Clinical Trial Registration NumberNCT01458301. To evaluate the efficacy and safety of three dose levels of relugolix, a gonadotropin-releasing hormone receptor antagonist, compared with placebo and leuprorelin in women with endometriosis-associated pain. Phase 2, multicenter, randomized, double-blind, placebo-controlled study. Hospitals and clinics. Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain. During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection. Primary endpoint was the change from baseline in mean visual analog scale score for pelvic pain during 28 days before the end of treatment. The mean changes in mean visual analog scale score for pelvic pain were –3.8 mm in the placebo group; –6.2, –8.1, and –10.4 mm in the relugolix 10-mg, 20-mg, and 40-mg groups; respectively; and –10.6 mm in the leuprorelin group. The major adverse events with relugolix were hot flush, metrorrhagia, menorrhagia, and irregular menstruation, and bone mineral density decrease in a dose–response manner, which were also observed in the leuprorelin group with a frequency comparable with that in the relugolix 40-mg group. Oral administration of relugolix alleviated endometriosis-associated pain in a dose–response manner and was generally well tolerated. Relugolix 40 mg demonstrated efficacy and safety comparable with those of leuprorelin.
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