A randomized single-center study to compare the efficacy and tolerability of tadalafil once daily plus lidocaine anesthetic spray on premature ejaculation

Eur Rev Med Pharmacol Sci. 2017 Mar;21(5):1036-1040.


Objective: The use of topical local anesthetics in the form of creams, gel or spray is the oldest method of retarding ejaculation. However, several studies have suggested that phosphodiesterase type 5 inhibitors (5-PDEiS) show a potential therapeutic use in the treatment of premature ejaculation (PE). The aim of this study was to compare the efficacy and tolerability of tadalafil-only, tadalafil plus local anesthetic spray (lidocaine), and topical lidocaine spray-only before intercourse on the intravaginal ejaculatory latency time (IELT) of patients with lifelong PE.

Patients and methods: The study included 78 men in stable heterosexual, monogamous relationships (of ≥3 months) who were diagnosed with lifelong PE. The patients were divided into three groups: G1: 25 patients who received lidocaine spray 10 g/100 ml at 5 min before intercourse; G2: 27 patients who received tadalafil 5 mg once daily; G3: 26 patients who treated with tadalafil once daily plus lidocaine spray before planned sexual activity. The treatments were continued for up to three months in all groups. Moreover, the quality of their sexual attempts was rated on a 5-point scale. Follow-up was made at 1-month and 3-month.

Results: Not statistically significant differences emerged between the three groups at baseline. Mean ejaculatory latency time at the 3-month follow-up in G1, G2 and G3 was 3.7±1.3, 3.4±1.5, 5.6±1.7 (p<0.001). Mean satisfaction score was at the 3-month follow-up in G1: 2.8±1.4, in G2: 2.9±1.8, and G3: 3.7±1.5 (p<0.002). None of the patients withdrew from the study because of these adverse events.

Conclusions: This study demonstrates that tadalafil used daily has a role on treatment in lifelong PE. This action is valid when combined strategically to the synergistic action of lidocaine spray applied before intercourse increasing significantly the mean IELT.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Anesthetics, Local / therapeutic use*
  • Ejaculation
  • Humans
  • Lidocaine / therapeutic use*
  • Male
  • Premature Ejaculation*
  • Tadalafil / therapeutic use*
  • Vasodilator Agents / therapeutic use*


  • Anesthetics, Local
  • Vasodilator Agents
  • Tadalafil
  • Lidocaine