Santa Clara Valley Medical Center, Santa Clara, CA, USA.
J Sex Med. 2013 Oct;10(10):2506-17. doi: 10.1111/jsm.12272. Epub 2013 Aug 12.
To assess the efficacy and safety of the selective oxytocin receptor antagonist epelsiban in the treatment of premature ejaculation (PE).
Double-blind, randomized, parallel-group, placebo-controlled, stopwatch-monitored, phase 2, multicenter study (GSK557296; NCT01021553) conducted in men (N=77) 18-55 years of age, with PE defined as per International Society for Sexual Medicine consensus definition. Patients provided informed consent prior to a 4-week un-medicated run-in to determine baseline intravaginal ejaculatory latency times (IELT) recorded in an electronic diary. Patients needed to make a minimum of four intercourse attempts and have a mean IELT<65 seconds to be considered for randomization. Men with moderate-to-severe erectile dysfunction were excluded from the study. Eligible patients were randomized to placebo, epelsiban 50 mg, or 150 mg, taken 1 hour before sexual activity. Active treatment IELT times were recorded in an electronic diary, along with subjective measures of intercourse satisfaction, over an 8-week treatment period. The Modified Index of Premature Ejaculation and International Index of Erectile Function were completed at study visits.
Stopwatch timed IELT recordings and a modified version of the patient-reported outcome questionnaire the IPE were used in this study to determine the effect of epelsiban when taken orally prior to intercourse in subjects diagnosed with PE.
The baseline (mean) IELT for patients pretreatment was (0.52, 0.63, and 0.59 minutes) for placebo, epelsiban 50 mg and 150 mg, respectively. On-treatment, average geometric least squares means of the median IELT values (mean) were slightly higher in the 50 mg and 150 mg groups (0.72 and 0.69 minutes), respectively, vs. the placebo group (0.62 minutes). Headache was the most common adverse event, and rates were similar across all groups.
Epelsiban 50 mg and 150 mg were well tolerated, but did not result in a clinically or statistically significant change in IELT in men with PE, compared with placebo.
评估选择性催产素受体拮抗剂 epelsiban 治疗早泄（PE）的疗效和安全性。
这是一项在 18-55 岁男性中进行的、双盲、随机、平行组、安慰剂对照、秒表监测、2 期、多中心研究（GSK557296；NCT01021553），采用国际性行为医学协会共识定义来诊断 PE。患者在 4 周的无药物预处理期内提供知情同意，以确定电子日记中记录的基线阴道内射精潜伏期时间（IELT）。患者需要至少进行四次性交尝试，并且平均 IELT<65 秒才能被考虑随机分组。中度至重度勃起功能障碍的患者被排除在研究之外。符合条件的患者被随机分配至安慰剂、epelsiban 50mg 或 150mg，在性行为前 1 小时服用。在 8 周的治疗期间，电子日记中记录了活性治疗的 IELT 时间，以及性交满意度的主观测量。在研究访问时完成了改良早泄指数和国际勃起功能指数。
使用秒表计时 IELT 记录和改良患者报告结局问卷 IPE 来确定在诊断为 PE 的受试者中，在性交前口服 epelsiban 的效果。
患者治疗前的基线（平均）IELT 分别为（0.52、0.63 和 0.59 分钟），安慰剂、epelsiban 50mg 和 150mg 组。在治疗期间，50mg 和 150mg 组的中位 IELT 值的平均几何最小二乘均值（平均值）分别略高（0.72 和 0.69 分钟），安慰剂组为（0.62 分钟）。头痛是最常见的不良事件，且各治疗组发生率相似。
epelsiban 50mg 和 150mg 耐受良好，但与安慰剂相比，在 PE 男性中，并未导致 IELT 出现临床或统计学意义上的变化。
