Objective: The aim of the study is to evaluate the efficacy and safety of nasal spray, containing Clomipramine hydrochloride (Clom spray) in the treatment of men with premature ejaculation (PE).Material and Methods: After the approval of the National Ethics Committee, from 2011 to 2013, in Republican Specialized Center of Urology examined and treated 54 patients with premature ejaculation, who were appointed Clomipramine hydrochloride 5mg as a nasal spray in both nostrils for 1 hour before sexual intercourse (on demand)for 8-weeks (group A).The second group consisted of 22 patients with placebo (distilled water nasal spray in both nostrils for 1 hour before sexual intercourse for 8-weeks)-group B.All patients were included in the study according to the strict inclusion and exclusion criteria.The prototype of our study was the research of Wei Lu et al."Modulation of brain delivery and copulation by intranasal apomorphine hydrochloride" (2007y).The primary endpoint was score of China Index of Premature Ejaculation (CIPE) and the measurement of intravaginal ejaculation latency time (IELT), secondary endpoints include mean intercourse satisfaction domain and adverse drug effects.