Waldinger 1998.

Study characteristics
Methods	Study design: randomized controlled, parallel‐group trial Setting/country: Department of Psychiatry and Neurosexology, Leyenburg Hospital, The Hague, The Netherlands Dates study conducted: NR
Participants	Inclusion criteria: Heterosexual men age 18–75 years who experienced PE In a steady sexual relationship with a female partner who was able to participate in the study Exclusion criteria: ED Inhibited male orgasm Alcohol and substance abuse Mental disorders Physical illnesses Use of medication including psychoactive medications Total number of participants randomized: 60 Total length of study: 6 weeks Group 1 (fluoxetine): Number of participants randomized: 12 Age (mean): 38 (SD 7) years Baseline IELT (mean): 18 (SD 13) seconds Group 2 (fluvoxamine): Number of participants randomized: 12 Age (mean): 44 (SD 10) years Baseline IELT (mean): 18 (SD 13) seconds Group 3 (paroxetine): Number of participants randomized: 12 Age (mean): 41 (SD 8) years Baseline IELT (mean): 18 (SD 13) seconds Group 4 (sertraline): Number of participants randomized: 12 Age (mean): 40 (SD 9) years Baseline IELT (mean): 18 (SD 13) seconds Group 5 (placebo): Number of participants randomized: 12 Age (mean): 45 (SD 4) years Baseline IELT (mean): 18 (SD 13) seconds
Interventions	Group 1: fluoxetine 20 mg daily Group 2: fluvoxamine 100 mg daily Group 3: paroxetine 20 mg daily Group 4: sertraline 50 mg daily Group 5: placebo daily
Outcomes	Primary outcomes: IELT How measured: by using stopwatch Time points measured: 0, 3, 6 weeks Secondary outcomes: Sexual desire How measured: questionnaire, designed by the investigators Time points measured: 0, 6 weeks Safety outcomes: Adverse effects How measured: Udvalg for Kliniske Undersøgelser Adverse Effect questionnaire Time points measured: on day before treatment and at weekly intervals at home during the 6 weeks of study Other outcomes: Psychopathology How measured: SCL‐90 questionnaire Time points measured: 0, 3, 6 weeks
Funding sources	Solvay Pharmaceuticals
Declarations of interest	NR
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "standard random number generator."
Allocation concealment (selection bias)	Unclear risk	Methods not described.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Likely appropriate blinding. Quote: "capsules [treatment and placebo] were identical."
Blinding of outcome assessment (detection bias) Participant‐reported outcomes	Low risk	Likely appropriately blinded. Quote: "patients in the first study were randomly assigned, in a double‐blind manner, to receive either fluoxetine 20 mg/day, fluvoxamine 100 mg/day, paroxetine 20 mg/day, sertraline 50 mg/day, or placebo in the form of 2 identical capsules per day given in a single morning dose."
Blinding of outcome assessment (detection bias) Investigator‐assessed outcomes	Unclear risk	Not explicitly described who was assessing adverse effects.
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	Unclear risk	Large proportion of participants excluded from final analysis (9/60) with no ITT performed.
Selective reporting (reporting bias)	High risk	No protocol available and adverse effects outcome was only partially reported in the results.
Other bias	Low risk	No additional sources of bias identified.