Xiaoqian Wang, Wenying Wang, Jingjing Li, Ruifang An, Lihong Chen, Jiajing Lin, Dabao Xu, Jin Qiu, Weihua Song, Mijiti Patiman, Hongjie Ruan, Gang Wang, Fengxia Xue, Xu Wang, Xiaowan Luo, Qi Ruan, Ling Shi, Chun Zhang, Lina Hu, Shijin Wang, Hong Shi, Xiaoli Wang, Songling Zhang, Yingxiong Li, Jing Lu, Baojin Wang, Hongyan Xu, Hong Ye, Bei Zhang, Chunlian Zhang, Sumin Qian, Qiong Wu, Wen Jia, Chuan Li, Qinping Liao
PURPOSE: To evaluate the efficacy and safety of oral ibrexafungerp (HS-10366) versus placebo in Chinese patients with vulvovaginal candidiasis (VVC). METHODS: A double-blind, placebo-controlled, randomized, multicenter phase III study was conducted in symptomatic VVC patients. Patients received (2:1) twice-daily oral ibrexafungerp 300 mg or matching placebo for 1 day. The primary endpoint was clinical cure (vulvovaginal signs and symptoms [VSS] score = 0) at test-of-cure (TOC) on day 11 ± 3...
April 3, 2024: Infection