Tadalafil and fluoxetine in premature ejaculation: prospective, randomized, double-blind, placebo-controlled study - PubMed

Introduction: Premature ejaculation (PE) is one of the most prevalent male sexual disorders, affecting millions of men around the world. This condition can lead to significant psychological distress, feelings of inadequacy, and relational difficulties, prompting a demand for effective treatment options. Men experiencing PE often seek solutions that can enhance their sexual experiences and improve their relationships. An ideal treatment would not only be effective but also safe, with minimal side effects, and capable of being integrated seamlessly into a man’s sexual routine.

Aim: This study aims to rigorously evaluate whether the combination of tadalafil, a phosphodiesterase-5 inhibitor known for its role in enhancing erectile function, and fluoxetine, a selective serotonin reuptake inhibitor commonly prescribed for anxiety and depressive disorders, can significantly prolong the intravaginal ejaculatory latency time (IELT) in men diagnosed with lifelong premature ejaculation. The hypothesis is that this synergistic approach may yield superior results compared to the use of each medication individually or a placebo.

Methods: A total of sixty male patients, all of whom were diagnosed with lifelong premature ejaculation and did not have erectile dysfunction, were enrolled in this clinical trial. The criteria for inclusion were men with an IELT of less than 90 seconds. Participants were randomly assigned into four distinct groups to assess the efficacy of different medication combinations: (1) tadalafil 20 mg combined with fluoxetine 90 mg, (2) fluoxetine 90 mg combined with a placebo, (3) tadalafil 20 mg combined with a placebo, and (4) two different placebo capsules for control. Prior to initiation of treatment, each participant was instructed to time their IELT using a stopwatch to establish a baseline measurement, and this process was repeated during the treatment period. Participants took fluoxetine 90 mg or a placebo once weekly and tadalafil 20 mg or a placebo within 36 hours prior to their anticipated sexual intercourse with a consistent partner. The follow-up period lasted for 12 weeks, during which patients were assessively monitored for changes in IELT. Statistical comparisons of IELT across the different groups were made using one-way ANOVA.

Results: The mean IELT of participants prior to the commencement of treatment was 51.3 seconds with a standard deviation of 23 seconds. Statistical analysis via one-way ANOVA revealed a significant difference in post-treatment IELT results for the combination treatment group in comparison to the placebo cohort (p < 0.001). Notably, the IELT showed marked improvement from baseline for patients receiving fluoxetine combined with tadalafil (increased from 49.57 seconds to 336.13 seconds, p < 0.001), fluoxetine alone (from 56.55 seconds to 233.62 seconds, p < 0.001), and tadalafil alone (from 49.26 seconds to 186.53 seconds, p = 0.001). Each treatment group experienced statistically significant increases in IELT when contrasted with the placebo group, which demonstrated only a modest increase from 49.86 seconds to 67.82 seconds (p = 0.042).

Conclusion: The findings of this study indicate that the combination of fluoxetine and tadalafil significantly enhances the IELT from baseline measurements in men suffering from lifelong premature ejaculation when juxtaposed with the effects of placebo, tadalafil alone, or fluoxetine alone. This suggests that this pharmacological combination could be a beneficial treatment strategy for men seeking to prolong ejaculation and improve sexual satisfaction.