AB53. Efficacy and safety of nasal spray containing clomipramine hydrochloride in treatment of men with premature ejaculation

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.

Results: Initial values CIPE in the group A made 28.9+3.6 points, in group B, 30.1+4.1 points. Initial values IELT in the group A made 28.3+2.3sec, in group B, 30.8+1.9sec. The final values CIPE in group A made 40.3+8.1 (+39.4%) points (P<0.01), while in group B, 32.4+6.1 (+2.2%). The final values IELT in group A made 82.6+4.2 (291.9%) sec, and group B-43.6 (+41.5%) seconds. The greatest changes of studied parameters (CIPE and IELT) achieved among patients receiving Clomipramine hydrochloride 5 mg as a nasal spray in both nostrils for 1 hour before sexual intercourse (on demand) during 8-weeks (group A). As for indicators of group B (placebo), some changes also took place in this group, but they are not on a reliable basis.

Results: We also compared the results of IELT and CIPE of groups with each together. Moreover, all indicators of group A were statistically higher than the rates in group B (P<0.01). It should be noted that tolerability was good. No serious side effects, that would require the withdrawal of the drug were not observed. Two patients from group A (3.7%) had nasal congestion that did not require the use of other drugs to resolve it.

Conclusions: This study showed that Clom spray was more efficacious than placebo and well tolerated. Adverse reactions were mild and self-limited. Further studies with different groups of patients are necessary to draw final conclusions on the efficacy and role of Clom spray in the treatment of PE.

Keywords: Efficacy; safety; premature ejaculation