Safarinejad 2008.

Study characteristics
Methods	Study design: randomized controlled, parallel‐group trial Setting/country: single institute, Tehran, Iran Dates study conducted: February 2004 to March 2006
Participants	Inclusion criteria: Married men with PE defined as IELT < 2 minutes that occurred in > 90% of sexual intercourse. None of the participants had received other treatment for PE for ≥ 4 weeks before the start of the study No other sexual disorders In a stable relationship with their wives for previous ≥ 6 months and possible sexual intercourse ≥ 1 per week Did not use condoms or topical anesthetics. They were also instructed not to pause during intercourse or to have interrupted intromission No obvious organic cause of PE, possible sexual intercourse ≥ 1 per week and initiation of the participant to seek medical help for what they considered PE. Exclusion criteria: ED according to IIEF Reduced sexual desire Inhibited male orgasm Chronic psychiatric or physical illness Alcohol or substance abuse Use of medication like including psychotropic medication Organic cause of PE including anatomical abnormalities, genital infection and neurologic disorder; organic illness causing limitation in SSRI use Serious relationship problems Total number of participants randomized: 212 Total length of study: 12 weeks Group 1 (dapoxetine): Number of participants randomized: 106 Age (mean): 35.7 (range 21–54) years Baseline IELT (mean): 22 seconds Number of participants with primary PE: 40 (37.7%) Group 2 (placebo): Number of participants randomized: 106 Age (mean): 36.3 (range 19–56) years Baseline IELT (mean): 29 seconds Number of participants with primary PE: 43 (40.6%)
Interventions	Group 1: dapoxetine 30 mg twice daily Group 2: placebo daily
Outcomes	Primary outcomes: IELT How measured: using a stopwatch Time points measured: every 2 weeks Secondary outcomes: Sexual satisfaction How measured: 0–5 scale proposed by Kim and Paick Time points measured: every 2 weeks Safety outcomes: Adverse effects How measured: reported by participants Time points measured: every 2 weeks and at end of treatment
Funding sources	None
Declarations of interest	None
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Likely random. Quote: "randomization table generated by the method of random permuted blocks."
Allocation concealment (selection bias)	Low risk	Quote: "interactive voice response system … Persons who geographically and operationally were independent from the study investigator did the randomization of the study."
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Likely appropriately blinded. Quote: "Treatment was administered in a randomized sequence that remained unknown to the patient and to the physician."
Blinding of outcome assessment (detection bias) Participant‐reported outcomes	Low risk	Likely appropriately blinded. Quote: "Treatment was administered in a randomized sequence that remained unknown to the patient."
Blinding of outcome assessment (detection bias) Investigator‐assessed outcomes	Unclear risk	Not explicitly described.
Blinding of outcome assessment (detection bias) IELT	Low risk	Objective measurement that is unlikely to be influenced by blinding.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	13/106 (12.2%) in dapoxetine arm and 10/106 (9.4%) in placebo arm excluded from final analysis.
Selective reporting (reporting bias)	Unclear risk	No protocol available.
Other bias	Low risk	No additional sources of bias identified.