The effects of dapoxetine on spermatogenesis and sexual hormones: An animal study

Document Type : Original Article


1 Associate Professor, Department of Urology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

2 Assistant Professor, Department of Hematology and Blood Bank, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

3 Assistant Professor, Department of Nanotechnology, Nanotechnology Research Center, Pharmaceutical Technology Institute, Faculty of Medicine, Mashhad University of Medical Science, Mashhad, Iran. Assistant Professor, Department of Nanotechnology, Clinical Research Development Unit, Faculty of Medicine, Mashhad University of Medical Science, Mashhad, Iran.

4 Resident, Department of Urology, Faculty of Medicine, Mashhad University of Medical Science, Mashhad, Iran.


Introduction: Premature ejaculation is one of the problems which men are facing. This disorder can affect the quality of life and in many cases, the fertility of couples. Recent studies have shown that the dapoxetine mechanism affects the spermatogenesis. However, so far, no study has been conducted on the impact of dapoxetine on sexual hormones and spermatogenesis. Therefore, the present study was performed with aim to examine the effects of dapoxetine on sexual hormones and spermatogenesis.
Methods: In this study, 32 male albino desert rats weighing 200 to 250 gr were used. The rats were randomly divided into four groups. The first group received saline solution (1mg/kg) via gavage. Groups 2 to 4 were subjected to intervention with dapoxetine at doses of 1, 2, and 4 ml/kg, respectively, administered through gavage. Pathological changes in the testicular, levels of luteinizing hormones, follicle-stimulating hormone, and testosterone were investigated in this study. Data analysis was done using SPSS software (version 22) and ANOVA, Fisher and post hoc tests. P<0.05 was considered statistically significant.
Results: Regarding the results of sexual hormones such as testosterone (p<0.001), luteinizing hormones (p=0.007), and follicle-stimulating hormone (p<0.001), there were significant differences between the mentioned four groups. The results showed that there was no evidence of hyperplasia, necrosis, edema, or maturation arrest in any of the testicular cells from the rat groups. However, spermatogenesis was observed in all rats from each of the four groups.
Conclusion: In general, the use of dapoxetine changes the level of sexual hormones; however, it had no effect on the pathology of testicular cells.


  1. Gillman N, Gillman M. Premature ejaculation: aetiology and treatment strategies. Medical sciences 2019; 7(11):102.
  2. Coskuner ER, Ozkan B. Premature ejaculation and endocrine disorders: a literature review. The world journal of men's health 2022; 40(1):38.
  3. Sarbazi F, Akbari E, Karimi A, Nouri B, Ardebili SN. The clinical outcome of laparoscopic surgery for endometriosis on pain, ovarian reserve, and cancer antigen 125 (CA-125): a cohort study. International Journal of Fertility & Sterility 2021; 15(4):275.
  4. Assasa MF, Mohammed ES, Moustafa OM, Abo Alfotoh AM. Histopathological study of the chronic toxic effects of dapoxetine administration on testes of male albino rats. The Egyptian Journal of Hospital Medicine 2019; 74(8):1698-701.
  5. Azarmehr N, Porhemat R, Roustaei N, Radmanesh E, Moslemi Z, Vanda R, et al. Melatonin-Attenuated Oxidative Stress in High-Risk Pregnant Women Receiving Enoxaparin and Aspirin. Evidence-Based Complementary and Alternative Medicine. 2023; 2023.
  6. McMahon CG. Dapoxetine: a new option in the medical management of premature ejaculation. Therapeutic advances in urology 2012; 4(5):233-51.
  7. Buvat J, Tesfaye F, Rothman M, Rivas DA, Giuliano F. Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. European urology 2009; 55(4):957-68.
  8. Hakemi MS, Nassiri AA, Nobakht A, Mardani M, Darazam IA, Parsa M, et al. Benefit of hemoadsorption therapy in patients suffering sepsis-associated acute kidney injury: a case series. Blood Purification 2022; 51(10):823-30.
  9. McMahon CG. Efficacy of dapoxetine in the treatment of premature ejaculation. Clinical Medicine Insights: Reproductive Health 2011; 5:CMRH-S7337.
  10. McCarty EJ, Dinsmore WW. Dapoxetine: an evidence-based review of its effectiveness in treatment of premature ejaculation. Core evidence 2012; 7:1.
  11. Tabatabaee S, Bahrami F, Janahmadi M. The critical modulatory role of spiny stellate cells in seizure onset based on dynamic analysis of a neural mass model. Frontiers in Neuroscience 2021; 15:743720.
  12. Ghiasi F, Hosseinzadeh Z, Nemati F, Kheiry M, Normohammadi A, Sharifi N. The Effect of Cognitive-Behavioral Therapy (CBT) on Anxiety Reduction in Critical Care Unit (CCU) Patients During Hospitalization. Journal of Intellectual Disability-Diagnosis and Treatment 2021; 9(3):304-10.
  13. Ghiasi F, Fashi FM. Ethical Climate of Operating Room of Educational Hospitals Affiliated To Ilam University of Medical Sciences from the Point of View of Anesthesia and the Operating Room Students. Indian Journal of Forensic Medicine & Toxicology 2019; 13(4).
  14. ElMazoudy R, AbdelHameed N, ElMasry A. Paternal dapoxetine administration induced deterioration in reproductive performance, fetal outcome, sexual behavior and biochemistry of male rats. International Journal of Impotence Research 2015; 27(6):206-14.
  15. Canat L, Erbin A, Canat M, Dinek M, Ça┼čkurlu T. Assessment of hormonal activity in patients with premature ejaculation. International braz j urol 2017; 43:311-6.
  16. Lee BH, Kim YK, Park SH. Using aripiprazole to resolve antipsychotic-induced symptomatic hyperprolactinemia: a pilot study. Progress in Neuro-Psychopharmacology and Biological Psychiatry 2006; 30(4):714-7.
  17. Grande G, Barrachina F, Soler-Ventura A, Jodar M, Mancini F, Marana R, et al. The role of testosterone in spermatogenesis: Lessons from proteome profiling of human spermatozoa in testosterone deficiency. Frontiers in Endocrinology 2022; 13:852661.
  18. Drury RH, Greenberg JW, Lerner M, Hellstrom WJ. Premature Ejaculation and Its Association with Serum Testosterone Levels: A Comprehensive Review. Androgens: Clinical Research and Therapeutics 2022; 3(1):91-104.