[Translation] A randomized, double-blind, placebo- and active drug-controlled, multicenter clinical trial on the efficacy and safety of lidocaine prilocaine aerosol in the treatment of primary premature ejaculation in adult men
主要目的:以山东百诺医药股份公司持有的利多卡因丙胺卡因气雾剂为试验药物,以Recordati Ireland Ltd.持证的利多卡因丙胺卡因气雾剂(商品名:Fortacin®)为参比制剂,同时以安慰剂为对照,评价试验药物对成年男性原发性早泄患者的有效性。
[Translation] Main objective: To evaluate the effectiveness of the test drug in adult male patients with primary premature ejaculation, using lidocaine prilocaine aerosol owned by Shandong Bainuo Pharmaceutical Co., Ltd. as the test drug, and lidocaine prilocaine aerosol (trade name: Fortacin®) licensed by Recordati Ireland Ltd. as the reference preparation, and placebo as the control.