Safarinejad et al. (1313. Safarinejad MR. Safety and efficacy of venlafaxine in the treatment of premature ejaculation: a double-blind, placebo-controlled, fixed-dose, randomised study. Andrologia. 2008; 40:49-55.) Tramadol 50mg (2929. Eassa BI, El-Shazly MA. Safety and efficacy of tramadol hydrochloride on treatment of premature ejaculation. Asian J Androl. 2013; 15:138-42.) Placebo (2828. Hamidi-Madani A, Motiee R, Mokhtari G, Nasseh H, Esmaeili S, Kazemnezhad E. The Efficacy and Safety of On-demand Tramadol and Paroxetine Use in Treatment of Life Long Premature Ejaculation: A Randomized Double-blind Placebo-controlled Clinical Trial. J Reprod Infertil. 2018; 19:10-15.) 8 weeks |
2006 Iran |
RCT |
IELT <2mins for >90% of the coitus |
-Age group 20-52 -Randomly assigned in two groups. -Drug taken 2 hours before sexual activity. -Patient followed 2 weekly till 8 weeks. |
IELT Sexual satisfaction domain values of IIEF |
Mean intercourse satisfaction domain values of the IIEF at 8 weeks in tramadol and plaeco group were 14 and 10 respectively. |
Salem et al. (1414. Salem EA, Wilson SK, Bissada NK, Delk JR, Hellstrom WJ, Cleves MA. Tramadol HCL has promise in on-demand use to treat premature ejaculation. J Sex Med. 2008;5:188-93.) Tramadol 25 mg (60) Placebo (60) 8 weeks |
2008 USA |
Prospective single blind Placebo controlled Cross over study |
DSM IV TR (IELT <2 mins in >80 % of coitus acts) |
-4 weeks of test period followed by 8 weeks of treatment duration -I week drug wash out period followed by crossover of therapy for 8 weeks again -Drug taken 1-2 hours before act. |
IELT Satisfaction over control of ejaculation Satisfaction with sexual function |
59/60 patients reported satisfactory control over ejaculation and significant benefits in sexual satisfaction |
Bar-or et al. (1515. Bar-Or D, Salottolo KM, Orlando A, Winkler JV. A randomized double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of the tramadol orally disintegrating tablet for the treatment of premature ejaculation within less than 2 minutes. Eur Urol. 2012; 61:736-43.) Tramadol 62mg ODT (206) Tramadol 89mg ODT (198) Placebo (200) 12 weeks |
2012 Multicentre |
RCT |
DSM IV TR IELT <2 mins |
Baseline 3 week screening period Followed by 3 week single blind placebo lead-in period Followed by 12 weeks of double blind treatment Drugs taken 2-8 hours before sex. |
IELT PEP |
NA |
Kaynar et al. (1616. Kaynar M, Kilic O, Yurdakul T. On-demand tramadol hydrochloride use in premature ejaculation treatment. Urology. 2012; 79:145-9.) Tramadol 25 mg (3030. Kurkar A, Elderwy AA, Abulsorour S, Awad SM, Safwat AS, Altaher A. A randomized, double-blind, placebo-controlled, crossover trial of “on-demand” tramadol for treatment of premature ejaculation. Urol Ann. 2015; 7:205-10.) Placebo (3030. Kurkar A, Elderwy AA, Abulsorour S, Awad SM, Safwat AS, Altaher A. A randomized, double-blind, placebo-controlled, crossover trial of “on-demand” tramadol for treatment of premature ejaculation. Urol Ann. 2015; 7:205-10.) 8 weeks |
2012 Turkey |
Single blind placebo controlled Crossover study |
IELT <1min for >90% of the coitus |
Drug taken 2 hours before sex. Two groups containing 30 patients were given either placebo or tramadol first followed by cross over |
IELT Ability to control ejacuation Sexual satisfaction scores |
Ejaculation control ability Tramadol group 2.83 vs. 1.5 for placebo Sexual satisfaction score Tramadol group 2.77 vs. 1.33 for placebo |
Eassa et al. (1717. Eassa BI, El-Shazly MA. Safety and efficacy of tramadol hydrochloride on treatment of premature ejaculation. Asian J Androl. 2013; 15:138-42.) Tramadol 25mg, 50mg and 100 mg Placebo lead in period |
2012 Egypt |
RCT |
NA |
Initially all patients were given placebo for 4 weeks followed by randomization into 3 weeks to receive different doses of tamadol for 24 weeks. Drug was given 2–3 h before sex |
IELT Satisfaction and control of ejaculation |
90% (270/300)) treated with tramadol reported an increase in penile rigidity. Tramadol 100 mg group had higher side effects. However none of the side effects were serious |
Khan et al. (1818. Khan AH, Rasaily D. Tramadol use in premature ejaculation: daily versus sporadic treatment. Indian J Psychol Med. 2013; 35:256-9.) Tramadol 100 mg 4 weeks daily and 4 weeks on demand |
2013 India |
RCT |
DSM IV TR IELT <2 mins |
One group of patients received 100 mg daily of tramadol for 4 weeks and then on demand every 2 or 8 h before coitus for next 4 weeks. Second group patients received placebo for 4 weeks daily and on demand for next 4 weeks 2 or 8 h prior to coitus. |
IELT |
NA |
Gameel et al. (1919. Gameel T, Tawfeek A, Abou Farha M, Bastawesy M, Bendary M, Gamasy A. 184 On-demand use of Tramadol, Sildenafil, Paroxetine and Local Anaesthetics for the Management of Premature Ejaculation: A Randomized Placebo-controlled Clinical Trial. The Journal of Sexual Medicine, 2018, 15, S57.) Tramadol 50 mg (2929. Eassa BI, El-Shazly MA. Safety and efficacy of tramadol hydrochloride on treatment of premature ejaculation. Asian J Androl. 2013; 15:138-42.) Sildenafil 50 mg (3030. Kurkar A, Elderwy AA, Abulsorour S, Awad SM, Safwat AS, Altaher A. A randomized, double-blind, placebo-controlled, crossover trial of “on-demand” tramadol for treatment of premature ejaculation. Urol Ann. 2015; 7:205-10.) Paroxetine (2828. Hamidi-Madani A, Motiee R, Mokhtari G, Nasseh H, Esmaeili S, Kazemnezhad E. The Efficacy and Safety of On-demand Tramadol and Paroxetine Use in Treatment of Life Long Premature Ejaculation: A Randomized Double-blind Placebo-controlled Clinical Trial. J Reprod Infertil. 2018; 19:10-15.) Local anesthetic (3030. Kurkar A, Elderwy AA, Abulsorour S, Awad SM, Safwat AS, Altaher A. A randomized, double-blind, placebo-controlled, crossover trial of “on-demand” tramadol for treatment of premature ejaculation. Urol Ann. 2015; 7:205-10.) Placebo (2727. Gameel TA, Tawfik AM, Abou-Farha MO, Bastawisy MG, El-Bendary MA, El-Gamasy Ael-N. On-demand use of tramadol, sildenafil, paroxetine and local anaesthetics for the management of premature ejaculation: A randomised placebo-controlled clinical trial. Arab J Urol. 2013; 11:392-7.) 4 weeks |
2013 Egypt |
Single blind placebo controlled |
IELT <2 min in >75% of sexual acts over a 2 week period |
4 week run in period followed by 4 weeks of treatment period. Tramadol given 2 hours before sex whereas sildenafil, paroxetine and local anesthetic given 1 hour, 4 hours and 15 mins prior to the act |
IELT Sexual satisfaction score |
Sexual satisfaction score was 3.7 in tramadol group vs. 1.18 in placebo group. |
Kurkar et al. (2020. Kurkar A, Elderwy AA, Abulsorour S, Awad SM, Safwat AS, Altaher A. A randomized, double-blind, placebo-controlled, crossover trial of “on-demand” tramadol for treatment of premature ejaculation. Urol Ann. 2015;7:205-10.) Tramadol 50mg and 100mg Placebo For 8 weeks |
2015 Egypt |
RCT with crossover design |
NA |
Study subjects were randomized into 3 groups to receive three treatments. Group 1: 50 mg tramadol, placebo and tramadol 100mg Group 2: 100 mg tramadol, placebo and 50mg tramadol Group 3: 100mg tramadol, 50 mg tramadol and placebo. |
IELT |
NA |
Hamidi-Madani et al. (2121. Hamidi-Madani A, Motiee R, Mokhtari G, Nasseh H, Esmaeili S, Kazemnezhad E. The Efficacy and Safety of On-demand Tramadol and Paroxetine Use in Treatment of Life Long Premature Ejaculation: A Randomized Double-blind Placebo-controlled Clinical Trial. J Reprod Infertil. 2018; 19:10-15.) Tramadol 50mg Paroxetine 20mg Placebo 12 weeks |
2018 Iran |
RCT |
IELT<1 min |
Study subjects randomized into three groups after a 3 weeks lead-in period and subjects were reassessed after 12 weeks. Drug taken 2-3 hours prior to act. |
IELT PEP |
PEP score at 12 weeks were 13.3, 11.3 and 9.97 for tramadol, paroxetine and placebo respectively. |