Tadalafil and fluoxetine in premature ejaculation: prospective, randomized, double-blind, placebo-controlled study - PubMed
Introduction: Premature ejaculation (PE) is a prevalent male sexual dysfunction that can lead to distress in men as well as their partners. Consequently, there is a critical demand for an ideal treatment that is both effective and reliable. Many men suffering from this condition, as well as their partners, are searching for solutions that can enhance their sexual experiences and improve intimacy. Addressing PE effectively can lead to better overall sexual health and satisfaction.
Aim: This study aims to assess whether the combination of a phosphodiesterase-5 inhibitor, tadalafil, alongside a selective serotonin reuptake inhibitor, fluoxetine, can lead to an increase in intravaginal ejaculatory latency time (IELT) among men specifically diagnosed with lifelong premature ejaculation. The objective is to determine if this pharmacological synergy can produce a significant and clinically meaningful enhancement in the duration before ejaculation during sexual activity.
Methods: A total of sixty male patients diagnosed with lifelong premature ejaculation—who did not exhibit erectile dysfunction (ED)—and who had an IELT of less than 90 seconds were recruited for the study. Participants were randomized into four distinct treatment groups which included: (1) tadalafil 20 mg combined with fluoxetine 90 mg, (2) fluoxetine 90 mg paired with a placebo, (3) tadalafil 20 mg alongside a placebo, and (4) two different placebo capsules (control). Participants were instructed to accurately measure their IELT using a stopwatch before starting the treatment as well as throughout the duration of the study. Fluoxetine 90 mg or placebo was administered once a week in conjunction with tadalafil 20 mg or placebo within a 36-hour window prior to anticipated sexual intercourse with a regular partner. A follow-up period of 12 weeks allowed for the collection of relevant data to analyze the efficacy of the treatment. The statistical comparisons of IELT results across each group were conducted utilizing one-way ANOVA.
Results: The average IELT recorded before the initiation of treatment was 51.3 seconds, with a standard deviation of +/- 23 seconds. Upon application of one-way ANOVA, a statistically significant differentiation in post-treatment IELT values was established among the various treatment arms compared to the placebo group (p < 0.001). Participants receiving the combination of fluoxetine and tadalafil exhibited a remarkable increase in IELT, from a baseline of 49.57 seconds (± 25.87) to 336.13 seconds (± 224.77) (p < 0.001). In separate evaluations, fluoxetine alone enhanced IELT from 56.55 seconds (± 18.55) to 233.62 seconds (± 105.08) (p < 0.001), while tadalafil alone increased IELT from 49.26 seconds (± 19.43) to 186.53 seconds (± 159.05) (p = 0.001). Each treatment group's improvements were statistically significant when contrasted with the placebo group's IELT change, which went from 49.86 seconds (± 19.43) to 67.82 seconds (± 46.18) (p = 0.042).
Conclusion: The combination therapy of fluoxetine with tadalafil demonstrated a statistically significant enhancement in the IELT from baseline measurements in men afflicted with lifelong premature ejaculation when juxtaposed against placebo, tadalafil, or fluoxetine administered independently. This study highlights the potential benefits of dual pharmacotherapy in treating premature ejaculation, offering a promising option for those seeking greater control over their sexual function.