McMahon 1998.

Study characteristics
Methods	Study design: randomized controlled, cross‐over study Setting/country: St. Luke's Hospital, Sydney, Australia Dates study conducted: NR
Participants	Inclusion criteria: Age ≥ 18 years In a stable, monogamous heterosexual relationship for ≥ 6 months Planning to maintain this relationship for the duration of the study PE according to DSM‐IV‐TR criteria for PE for ≥ 6 months prior to enrolment and had a baseline IELT ≤ 2 minutes in ≥ 75% of a minimum of 4 evaluable sexual intercourse events during a treatment‐free 4‐week baseline period, and reported at least "moderate" ejaculation‐related personal distress or interpersonal difficulty Exclusion criteria: History of medical or psychiatric illness, including uncontrolled hypertension, hyperprolactinemia or untreated hypothyroidism History of medical events that were associated with the onset of PE Sexual dysfunction in either partner except PE in the man (including history of ED based on an IIEF Erectile Function domain score < 21 at screening) History of HIV, HBsAg or hepatitis C (except for people from Korea, inactive HBsAg carriers with normal liver function tests were allowed into the trial) Concomitant use of SSRIs or tricyclic antidepressants Known hypersensitivity to SSRIs or serotonin‐norepinephrine reuptake inhibitors Total number of participants randomized: 37 Total length of study: 12 weeks Group 1 (sertraline): Number of participants randomized: 19 Age (mean): 41 (range 19–70) years Baseline IELT (mean): 0.3 minutes Group 2 (placebo): Number of participants randomized: 18 Age (mean): 41 (range 19–70) years Baseline IELT (mean): 0.3 minutes
Interventions	Group 1: sertraline 50 mg Group 2: placebo daily
Outcomes	Primary outcomes: IELT How measured: using a stopwatch by partner Time points measured: every week for 12 weeks Safety outcomes: Adverse effects How measured: reported by participants Time points measured: anytime
Funding sources	NR
Declarations of interest	NR
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "single blind;" "placebo tablets were identical to the active drug." Likely participants were blinded but personnel were not blinded
Blinding of outcome assessment (detection bias) Participant‐reported outcomes	Low risk	Single blind. Likely participants were blinded. Quote: "placebo were identical to the active drug."
Blinding of outcome assessment (detection bias) Investigator‐assessed outcomes	High risk	Assessors unlikely blinded. Quote: "single blind study."
Blinding of outcome assessment (detection bias) IELT	Low risk	Objective measurement that was unlikely to be influenced by blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants that were randomized appeared to be included in final analysis.
Selective reporting (reporting bias)	Unclear risk	No protocol available.
Other bias	Low risk	No additional sources of bias identified.