a Department of Urology , Università Vita-Salute San Raffaele , Milan , Italy.
b Division of Experimental Oncology/Unit of Urology; URI , IRCCS Ospedale San Raffaele , Milan , Italy.
Expert Opin Investig Drugs. 2018 Jul;27(7):583-593. doi: 10.1080/13543784.2018.1495707. Epub 2018 Jul 11.
The prevalence of sexual dysfunctions has increased over the last decades; despite a number of available treatments for erectile dysfunction (ED), premature ejaculation (PE), and Peyronie's disease (PD), still several unmet therapeutic needs deserve to be fulfilled. The aim of this review is to detail on phase I and II clinical trials investigating novel medical treatments for ED, PE, and PD.
We conducted a systematic review of the literature including both published and ongoing phase I and II registered trials focused on medical treatment of ED, PE, and PD during the last 5 years. A total of 35 trials have been identified. Most studies (63%) investigated ED treatments and 26% were still ongoing. Stem cells (SCs) therapy was assessed in 28% of trials.
SCs therapy represent a promising treatment for ED although only few patients have been treated to date. Likewise, the oral selective oxytocin receptor antagonists for treating PE showed excellent safety profile and deserve further investigations in phase III trials. Preliminary results of novel topical treatments for PD with fibrinolytic and antiinflammatory drugs are encouraging, but urgently need to be confirmed in large placebo-controlled trials.
过去几十年来，性功能障碍的患病率有所上升；尽管有许多治疗勃起功能障碍（ED）、早泄（PE）和阴茎硬结症（PD）的方法，但仍有一些未满足的治疗需求需要满足。本综述的目的是详细介绍正在研究治疗 ED、PE 和 PD 的新型医学治疗方法的 I 期和 II 期临床试验。
我们对过去 5 年中关于 ED、PE 和 PD 医学治疗的已发表和正在进行的 I 期和 II 期注册试验进行了系统的文献回顾。共确定了 35 项试验。大多数研究（63%）都在调查 ED 治疗方法，其中 26%仍在进行中。有 28%的试验评估了干细胞（SCs）疗法。
SCs 疗法是治疗 ED 的一种很有前途的方法，尽管迄今为止只有少数患者接受了治疗。同样，口服选择性催产素受体拮抗剂治疗 PE 的安全性极好，值得在 III 期临床试验中进一步研究。新型局部治疗 PD 的纤维蛋白溶解和抗炎药物的初步结果令人鼓舞，但迫切需要在大型安慰剂对照试验中得到证实。
