2. Baseline characteristics.
| Study | Intervention(s) and comparator(s) | Duration of intervention | Trial period | Country | Setting | Age in years (mean) | Baseline IELT in minutes (mean) | Number of participants with primary/secondary PE |
| Ahn 1996 | I1: fluoxetine 20 mg daily for first 1 week and 40 mg daily for remaining 5 weeks after breakfast C1: placebo daily |
6 weeks | NR | South Korea | Outpatient | 39.8 (range 34–48) | 0.78 (range 0.17–2.0) | NA/NA |
| 39.8 (range 34–48) | 0.78 (range 0.17–2.0) | NA/NA | ||||||
| Athanasios 2007 | I1: duloxetine 20 mg daily for 1 week followed by 40 mg daily C1: placebo daily |
12 weeks | NR | Greece | Academic | 31.35 (SD 8.23) | 0.63 (SD 0.27) | NA/NA |
| 32.65 (SD 7.49) | 0.58 (SD 0.30) | NA/NA | ||||||
| Atmaca 2002 | I1: citalopram 20 mg daily up to 60 mg C1: placebo daily |
8 weeks | NR | Turkey | Outpatient | Range 24–46 | 0.55 (SD 0.29) | NA/NA |
| Range 24–46 | 0.50 (SD 0.24) | NA/NA | ||||||
| Biri 1998 | I1: sertraline 50 mg C1: placebo daily |
4 weeks | 1995–1997 | Turkey | Outpatient | NR | 0.68 (SD 0.21) | NA/NA |
| NR | 0.72 (SD 0.33) | NA/NA | ||||||
| Buvat 2009 | I1: dapoxetine 30 mg on‐demand I2: dapoxetine 60 mg on‐demand C1: placebo daily |
24 weeks | 2004–2006 | France | Academic | 39.6 (SD 9.53) | 0.9 (SD 0.50) | NA/NA |
| 40.5 (SD 9.62) | 0.9 (SD 0.49) | NA/NA | ||||||
| 40.1 (SD 9.98) | 0.9 (SD 0.51) | NA/NA | ||||||
| Farnia 2009 | I1: citalopram 20 mg on‐demand C1: placebo daily |
4 weeks | 2006–2007 | Iran | Outpatient | 34.28 (SD 6.67) | 1.11 (SD 0.61) | NA/NA |
| 33.76 (SD 5.93) | 1.10 (SD 0.56) | NA/NA | ||||||
| Gameel 2013 | I1: paroxetine 20 mg on‐demand + lubricating jelly C1: placebo on‐demand + lubricating jelly |
4 weeks | 2009–2012 | Egypt | Outpatient | NR | 0.16 (SD 0.47) | NA/NA |
| Gong 2011 | I1: paroxetine 20 mg daily C1: placebo daily |
30 days | NR | China | likely outpatient | 26.8 (SD 5.5) | 0.89 (SD 0.21) | NA/NA |
| 29.2 (SD 6.7) | 0.97 (SD 0.18) | |||||||
| Hamidi Madani 2016 | I1: tramadol 50 mg I2: paroxetine 20 mg C1: placebo |
12 weeks | NR | Iran | Outpatient | NR | NR | NA/NA |
| NR | NR | NA/NA | ||||||
| NR | NR | NA/NA | ||||||
| Kara 1996 | I1: fluoxetine 20 mg daily C1: placebo daily |
NR | NR | Turkey | Outpatient | Range 15–50 | 0.42 (SD 0.21) | NA/NA |
| Range 15–50 | 0.5 (SD 0.14) | NA/NA | ||||||
| Kaufman 2009 | I1: dapoxetine 60 mg on‐demand C1: placebo on‐demand |
9 weeks | NR | USA and Canada | Outpatient | 41.8 (SD 9.80) | NR | NA/NA |
| 40.98 (SD 9.71) | NR | NA/NA | ||||||
| Khelaia 2012 | I1: paroxetine 20 mg I2: paroxetine 20 mg 2–3 hours before intercourse C1: placebo |
4 weeks | NR | Georgia | Academic | 22.7 (range 19–39) | NR | NA/NA |
| 22.7 (range 19–39) | NR | NA/NA | ||||||
| 22.7 (range 19–39) | NR | NA/NA | ||||||
| Kim 1998 | I1: fluoxetine 40 mg daily for 1 week then 80 mg for 3 weeks I2: sertraline 100 mg for 1 week then 200 mg for 3 weeks C1: placebo daily |
16 weeks | NR | South Korea | Academic | 44 (range 30–60) | 0.77 (SD 0.68) | NA/NA |
| 44 (range 30–60) | 0.77 (SD 0.68) | NA/NA | ||||||
| 44 (range 30–60) | 0.77 (SD 0.68) | NA/NA | ||||||
| Mattos 2008 | I1: fluoxetine 90 mg daily I2: fluoxetine 90 mg daily + tadalafil 20 mg on‐demand C1: placebo daily C2: placebo + tadalafil 20 mg on‐demand |
12 weeks | NR | Brazil | Academic | 50 (SD 8.51) | 0.94 (SD 0.31) | NA/NA |
| 42.81 (SD 7.73) | 0.83 (SD 0.43) | NA/NA | ||||||
| 45.93 (SD 9.96) | 0.83 (SD 0.31) | NA/NA | ||||||
| 43.2 (SD 11.3) | 0.83 (SD 0.32) | NA/NA | ||||||
| McMahon 1998 | I1: sertraline 50 mg C1: placebo daily |
12 weeks | NR | Australia | Academic | 41 (range 19–70) | 0.3 | NA/NA |
| 41 (range 19–70) | 0.3 | NA/NA | ||||||
| McMahon 1999 |
Study 1: I1: paroxetine 20 mg C1: paroxetine as needed 3–4 hours before planned sexual intercourse |
17 weeks | NR | Australia | Academic | 39.5 | 0.3 | 19/7 |
| 39.5 | 0.3 | 19/7 | ||||||
|
Study 2: I2: paroxetine 10 mg for 3 weeks then 20 mg paroxetine as needed for 4 weeks C2: placebo daily for 3 weeks then placebo daily for 4 weeks |
40.5 | 0.5 | 32/10 | |||||
| 40.5 | 0.5 | 32/10 | ||||||
| McMahon 2010 | I1: dapoxetine 30 mg on‐demand I2: dapoxetine 60 mg on‐demand C1: placebo daily |
12 weeks | 2005–2006 | Multicenter in Asia/Pacific | Academic | 41.2 (SD 10.74) | 3.9 | 92 (42.2%)/NA |
| 41.0 (SD 10.78) | 4.2 | 92 (42.2%)/NA | ||||||
| 40.6 (SD 9.71) | 2.4 | 96 (45.9%)/NA | ||||||
| McMahon 2013 | I1: dapoxetine 30 mg on‐demand, from week 4 up to 60 mg if tolerated + PDE5 inhibitor taken 1–3 hours prior to sexual intercourse C1: placebo daily + PDE5 inhibitor taken 1–3 hours prior to intercourse |
12 weeks | 2010–2011 | Australia | Academic | 49.5 (SD 11.23) | NR | 92 (42.2%)/NA |
| 47.9 (SD 11.96) | NR | 96 (45.9%)/NA | ||||||
| Mendels 1995 | I1: sertraline 50 mg daily that could be titrated up to 200 mg daily C1: placebo daily |
10 weeks | NR | USA | Academic | NR | 0.98 (SD 1.15) | NA/NA |
| NR | 1.10 (SD 1.35) | NA/NA | ||||||
| Na 1996 | I1: sertraline 50 mg at night that could be titrated up to 100 mg daily C1: placebo daily |
6 weeks | NR | South Korea | Academic | NR | NR | NA/NA |
| NR | NR | |||||||
| Novaretti 2002 | I1: fluoxetine 20 mg C1: placebo daily |
20 weeks | 1998–2000 | Brazil | Academic | 37.4 (SD 10.7) | 1.01 (SD 0.86) | NA/NA |
| 37.4 (SD 10.7) | 1.05 (SD 1.07) | NA/NA | ||||||
| Pryor 2006 | I1: dapoxetine 30 mg on‐demand 1–3 hours before anticipated sexual activity I2: dapoxetine 60 mg on‐demand 1–3 hours before anticipated sexual activity C1: placebo on‐demand 1–3 hours before anticipated sexual activity |
12 weeks | 2003–2004 | USA | Academic | 40.3 (SD 9.10) | 0.90 (SD 0.47) | 563/227 |
| 40.9 (SD 9.09) | 0.92 (SD 0.50) | 571/234 | ||||||
| 40.3 (SD 9.55) | 0.91 (SD 0.48) | 560/248 | ||||||
| Safarinejad 2006b | I1: dapoxetine 60 mg daily I2: paroxetine 20 mg daily C1: placebo daily |
12 weeks | 2003–2005 | Iran | Academic | 33.4 (range 20–50) | 0.63 | 64 (61.5%)/NA |
| 34.6 (range 21–49) | 0.52 | 63 (60.0%)/NA | ||||||
| 34.3 (range 21–50) | 0.57 | 11 (44.0%)/NA | ||||||
| Safarinejad 2006c | I1: citalopram 30 mg C1: placebo daily |
6 months | NR | Iran | Academic | 32 (21–49) | 0.53 | 10/16 |
| 34 (21–49) | 0.47 | 11/14 | ||||||
| Safarinejad 2007 | I1: escitalopram 10 mg daily C1: placebo daily |
12 weeks | 2003–2005 | Iran | Academic | 33.5 (range 21–44) | NR | 87 (70%)/NA |
| 33.3 (range 19–46) | NR | 88 (69.8%)/NA | ||||||
| Safarinejad 2008 | I1: dapoxetine 30 mg daily C1: placebo daily |
12 weeks | 2004–2006 | Iran | Academic | 35.7 (range 21–54) | 0.37 | 40 (37.7%)/NA |
| 36.3 (range 19–56) | 0.48 | 43 (40.6%)/NA | ||||||
| Shang 2012 | I1: citalopram 20 mg daily C1: placebo daily |
4 weeks | 2011–2012 | China | Academic | 39.1 (SD 2.5) | 0.91 (SD 0.18) | NA/NA |
| 37.8 (SD 2.8) | 0.95 (SD 0.17) | |||||||
| Tuncel 2008 | I1: sertraline 50 mg nightly for 2 months C1: placebo daily |
8 weeks | NR | Turkey | Academic | 36.9 (median) (SD 6.9) | NR | NA/NA |
| 34.9 (median) (SD 9.0) | NR | NA/NA | ||||||
| Waldinger 1994 | I1: paroxetine 20 mg daily for 1 week and then 40 mg daily from week 2–6 C1: placebo daily |
6 weeks | NR | The Netherlands | Outpatient | 41 (range 27–48) | NR | 7/8 (87.5%)/NA |
| 38 (range 30–47) | NR | 7/9 (77.7%)/NA | ||||||
| Waldinger 1998 | I1: fluoxetine 20 mg daily I2: fluvoxamine 100 mg daily I3: paroxetine 20 mg daily I4: sertraline 50 mg daily C1: placebo daily |
6 weeks | NR | The Netherlands | Outpatient | 38 (SD 7.0) | 0.3 (SD 0.22) | NA/NA |
| 44 (SD 10.0) | 0.3 (SD 0.22) | NA/NA | ||||||
| 41 (SD 8.0) | 0.3 (SD 0.22) | NA/NA | ||||||
| 40 (SD 9.0) | 0.3 (SD 0.22) | NA/NA | ||||||
| 45 (SD 4.0) | 0.3 (SD 0.22) | NA/NA | ||||||
| Yilmaz 1999 | I1: fluoxetine 20 mg daily C1: placebo |
1 month | 1997–1997 | Turkey | Academic | 36.5 (range 22–56) | 1.2 (SD 1.0) | NA/NA |
| 37.3 (range 24–58) | 1.1 (SD 1.1) | NA/NA |
C: comparator; I: intervention; IELT: intravaginal ejaculatory latency time; NA: not available; NR: not reported; PDE5: phosphodiesterase‐5; PE: premature ejaculation; SD: standard deviation.