Evaluation of the efficacy and safety of different doses of daily paroxetine in patients with lifelong premature ejaculation: a prospective randomized crossover study

Sameh Fayek GamalEl Din; Ahmed Raef Sadek; Mohamed Yousry Elamir; Mohamed Ahmed Ateya; Hesham Hanafy Saber; Mahmoud Fawzy Ghaly

doi:10.1007/s11255-025-04921-4

Evaluation of the efficacy and safety of different doses of daily paroxetine in patients with lifelong premature ejaculation: a prospective randomized crossover study

Int Urol Nephrol. 2025 Dec 4. doi: 10.1007/s11255-025-04921-4. Online ahead of print.

Authors

Sameh Fayek GamalEl Din¹, Ahmed Raef Sadek², Mohamed Yousry Elamir², Mohamed Ahmed Ateya³, Hesham Hanafy Saber², Mahmoud Fawzy Ghaly²

Affiliations

¹ Department of Andrology and STDs Kasr Al-Ainy, Faculty of Medicine, Cairo University, Al-Saray Street, El Manial, Cairo, 11956, Egypt. samehfayek@kasralainy.edu.eg.
² Department of Andrology and STDs Kasr Al-Ainy, Faculty of Medicine, Cairo University, Al-Saray Street, El Manial, Cairo, 11956, Egypt.
³ Department of Urology, Kasr Alainy Faculty of Medicine, Cairo University, Cairo, Egypt.

PMID: 41345357
DOI: 10.1007/s11255-025-04921-4

Abstract

Purpose: Evidence regarding the optimal dose of paroxetine for lifelong premature ejaculation (LPE) with minimal adverse effects remains limited. This study evaluated the efficacy and safety of different paroxetine doses in patients with LPE.

Methods: The study recruited 100 LPE patients. Group (A) included 50 randomized LPE patients who received 12.5 mg paroxetine daily after breakfast for 3 months. Group (B) included 50 randomized LPE patients who received 20 mg paroxetine daily after breakfast for 3 months. After a 2-week washout, a crossover was executed for 3 months.

Results: Groups A and B demonstrated statistically significant increases in the scores of the Arabic index of premature ejaculation (AIPE) and the male sexual quality of life (QOL) throughout the follow-up period. Furthermore, upper and lower bounds of 95% confidence interval using estimates of fixed effects demonstrated significant changes in sequence in group A versus group B, treatment in group A versus group B and geometric mean intravaginal ejaculation latency time (IELT) in group A versus group B (- 4.13, - 0.26; - 4.16, - 0.27; - 8.02, - 4.15; p = 0.026 0.026, 0, respectively). Notably, upper and lower bounds of 95% confidence interval using estimates of fixed effects demonstrated significant changes in the occurrence of complications in group A versus group B (- 0.35, - 0.01, p = 0.041, respectively).

Conclusion: 12.5 mg paroxetine may be preferentially prescribed over 20 mg as it shows a comparable efficacy with lower adverse events and subsequent better tolerability and male sexual QOL.

Keywords: Different doses of daily paroxetine; Efficacy and safety of paroxetine; Geometric mean IELT; Lifelong premature ejaculation.