Efficacy and safety of daily use of tadalafil in treatment of patients with premature ejaculation: A randomised placebo‐controlled clinical trial

Abstract

The study aimed to evaluate the efficacy and safety of the once-daily use of 5 mg tadalafil in the treatment of patients with premature ejaculation (PE). In a single-blind placebo-controlled clinical study, it was carried out on 100 patients with PE. All patients were randomised equally divided into two groups (50 patients each). Group 1 was given placebo in the form of oral multivitamin tablet once a day for 6 weeks. Group 2 was given 5 mg tadalafil once a day for 6 weeks. All patients were asked to complete Arabic Index of Premature Ejaculation (AIPE) before and after the treatment. This study showed that there were no statistically significant differences between patients in the placebo and tadalafil groups regarding the mean values of the seven questions and total scores of the AIPE questionnaire before treatment (p value >.05). The mean values of the seven questions and total scores of AIPE questionnaire in the tadalafil group were significantly higher than the placebo group after treatment (p value = .001). This study concluded that once-daily use of 5 mg tadalafil for 6 weeks was effective and well tolerated in the treatment of patients with PE.

Phosphodiesterase-5 Inhibitors for Premature Ejaculation: Systematic Review and Meta-Analysis of Placebo-Controlled Trials

“…Eleven studies were excluded without useful data. Totally, seven (Abu El-Hamd, 2018; Abu El-Hamd & Abdelhamed, 2018; Atan et al, 2006; Aversa et al, 2009; Gameel et al, 2013; Mattos et al, 2008; McMahon et al, 2005) placebo-controlled studies were included in the meta-analysis. One study (Atan et al, 2006) only contained the data about the safety of PDE5Is.…”

“…The indicators IVELT and score of sexual satisfaction scale were used to assess the efficacy of PDE5Is in the treatment of PE. Six studies (Abu El-Hamd, 2018; Abu El-Hamd & Abdelhamed, 2018; Aversa et al, 2009; Gameel et al, 2013; Mattos et al, 2008; McMahon et al, 2005) including 431 patients compared the indicator IVELT and 3 (Abu El-Hamd & Abdelhamed, 2018; Gameel et al, 2013; McMahon et al, 2005) RCTs (261 patients) compared the score of sexual satisfaction scale between the group treated with PDE5Is and that treated with placebo. According to the analysis, patients who were treated with PDE5Is had significantly increased IVELT compared with those treated with placebo.…”

“…According to the analysis, patients who were treated with PDE5Is had significantly increased IVELT compared with those treated with placebo. The pooled effect estimates across 6 RCTs (Abu El-Hamd, 2018; Abu El-Hamd & Abdelhamed, 2018; Aversa et al, 2009; Gameel et al, 2013; Mattos et al, 2008; McMahon et al, 2005) was 2.60 min (95% CI [1.85, 3.36]; p < .00001; Figure 2). In addition, the meta-analysis of sexual satisfaction scale of the two groups shows that the PDE5I group had a higher score than the placebo group (MD 2.04; 95% CI [0.78, 3.30]; p = .002; Figure 3).…”

“…; DSM-IV ; American Psychiatric Association, 1994) to determine whether the patient has PE, while other studies mainly used the indicator IVELT to define PE. The diagnostic criterion for the included trials is IVELT <1 min (Abu El-Hamd, 2018; Abu El-Hamd & Abdelhamed, 2018), ≤1 min (Aversa et al, 2009), <1.5 min (Mattos et al, 2008), or <2 min (Gameel et al, 2013; McMahon et al, 2005). Although IVELT has different standards in different trials, the criterion of each trial is developed after scientific design and it doesn’t conflict with the inclusion criteria.…”

Combination or alone ? Which one is best in premature ejaculation treatment?

“…In a single-blind placebo-controlled study, usage of singledose 5 mg tadalafil daily for six weeks has been shown to be effective and well-tolerated in the treatment of premature ejaculatory patients [13] . In another study, in a significant percentage of patients after using chronic tadalafil for six months, a reduction in sexual function changes, such as premature ejaculation, was observed [14] .…”