Safarinejad 2006c.

Study characteristics
Methods	Study design: randomized controlled, parallel‐group trial Setting/country: University of Medical Sciences, Tehran, Iran Dates study conducted: NR
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 study No other sexual disorders In a stable relationship with their wives for the 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 such as 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: 58 Total length of study: 6 months Group 1 (citalopram): Number of participants randomized: 29 Age (mean): 32 (range 21–49) years Baseline IELT (mean): 0.53 minutes Number of participants with primary PE: 10 Number of participants with secondary PE: 16 Group 2 (placebo): Number of participants randomized: 29 Age (mean): 34 (range 21–49) years Baseline IELT (mean): 0.47 minutes Number of participants with primary PE: 11 Number of participants with secondary PE: 14
Interventions	Group 1: citalopram 20 mg daily Group 2: placebo daily
Outcomes	Primary outcomes: IELT How measured: NR Time points measured: every 2 weeks for 12 weeks, 3 and 6 months Secondary outcomes: Sexual satisfaction How measured: 0–5 scale proposed by Kim and Paick Time points measured: every 2 weeks for 12 weeks, 3 and 6 months Secondary outcomes: IIEF How measured: IIEF Questionnaire Time points measured: every 2 weeks for 12 weeks, 3 and 6 months Safety outcomes: Adverse effects How measured: reported by participants Time points measured: each visit
Funding sources	NR
Declarations of interest	NR
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was determined by a computer‐generated schedule."
Allocation concealment (selection bias)	Unclear risk	Methods not described.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Likely appropriate blinding. Quote: "Treatment was administered in a randomized sequence that remained unknown to the patient and to the physicians."
Blinding of outcome assessment (detection bias) Participant‐reported outcomes	Low risk	Likely appropriate blinding. Quote: "Treatment was administered in a randomized sequence that remained unknown to the patient and to the physicians."
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	3/29 (10.3%) in citalopram arm and 4/39 (13.7%) in placebo arm were not included.
Selective reporting (reporting bias)	Unclear risk	No protocol available.
Other bias	Low risk	No additional sources of bias identified.