[Translation] A randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of GS1-144 tablets in the treatment of moderate to severe vasomotor symptoms in Chinese postmenopausal women
主要目的:评价 GS1-144 治疗中重度 VMS 的有效性;
次要研究目的:1) 评价 GS1-144 治疗中重度 VMS 的其他有效性;2)评价 GS1-144 的安全性和耐受性。
探索性目的:1)评估 GS1-144 及其代谢物 M1 的群体药代动力学(PopPK)特征和暴露-效应分析;2) 评估 GS1-144 对睡眠困扰的改善;3)评估 GS1-144 对生活质量的改善;4)评估 GS1-144 对绝经后相关症状的改善;5)评估 GS1-144 对药效学(PD)标志物(黄体生成素[LH])的影响;6) 评估 GS1-144 片对于性激素(除外LH)和性激素结合球蛋白的影响;7)评估 GS1-144 片对骨代谢的影响。
[Translation] Primary objective: To evaluate the efficacy of GS1-144 in the treatment of moderate to severe VMS;
Secondary study objectives: 1) To evaluate the other efficacy of GS1-144 in the treatment of moderate to severe VMS; 2) To evaluate the safety and tolerability of GS1-144.
Exploratory objectives: 1) To evaluate the population pharmacokinetic (PopPK) characteristics and exposure-effect analysis of GS1-144 and its metabolite M1; 2) To evaluate the improvement of sleep disturbance by GS1-144; 3) To evaluate the improvement of quality of life by GS1-144; 4) To evaluate the improvement of postmenopausal related symptoms by GS1-144; 5) To evaluate the effect of GS1-144 on pharmacodynamic (PD) markers (luteinizing hormone [LH]); 6) To evaluate the effect of GS1-144 tablets on sex hormones (excluding LH) and sex hormone binding globulin; 7) To evaluate the effect of GS1-144 tablets on bone metabolism.