Yilmaz 1999.

Study characteristics
Methods	Study design: blinded, randomized controlled, parallel‐group trial Setting/country: Department of Urology and Neurology, Erciyes University Medical Faculty, Gevher Nesiber Research and Training Hospital, Kayseri, Turkey Dates study conducted: January 1997 to November 1997
Participants	Inclusion criteria: Not clearly described: men with PE (defined as uncontrolled occurrence of ejaculation just before or in the first few minutes of vaginal penetration) Exclusion criteria: Impotence Excessive alcohol intake or drug abuse Presence of psychopathology, mental retardation or organic disorder Total number of participants randomized: 40 Total length of study: 1 month Group 1 (fluoxetine): Number of participants randomized: 20 Age (mean): 36.5 (range 22–56) years Baseline IELT (mean): 1.2 (SD 1.0) minutes Group 2 (placebo): Number of participants randomized: 20 Age (mean): 37.3 (range 24–58) years Baseline IELT (mean): 1.1 (SD 1.1) minutes
Interventions	Group 1: fluoxetine 20 mg daily Group 2: placebo daily
Outcomes	Primary outcomes: IELT How measured: by participant according to participant choice Time points measured: 0, 4 weeks Secondary outcomes: Penile sensory threshold How measured: using ring electrode and electromyography machine Time points measured: 0, 4 weeks Safety outcomes: Adverse effects How measured: reported by participants Time points measured: anytime Other outcomes: Cortical sensory threshold How measured: using ring electrode and electromyography machine Time points measured: 0, 4 weeks Other outcomes: Sacral‐evoked response test How measured: using ring electrode and electromyography machine Time points measured: 0, 4 weeks
Funding sources	NR
Declarations of interest	NR
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Methods not described.
Allocation concealment (selection bias)	Unclear risk	Methods not described.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Study described as "double blind," but not clear whether personnel who interviewed participants at the end regarding adverse effects were blinded.
Blinding of outcome assessment (detection bias) Participant‐reported outcomes	Low risk	Likely appropriately blinded. Quote: "control group received placebo."
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 was unlikely to be influenced by blinding.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Number of participants included in the final analysis was not clearly described.
Selective reporting (reporting bias)	Unclear risk	No protocol available.
Other bias	Low risk	No additional sources of bias identified.

CGI: Clinical Global Impression; CGIC: Clinical Global Impression of Change; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders, fourth edition; DSM‐IV‐TR: Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision; ED: erectile dysfunction; HBsAg: hepatitis B surface antigen; IELT: intravaginal ejaculatory latency time; IIEF: International Index of Erectile Function; ITT: intention to treat; NR: not reported; PDE5: phosphodiesterase‐5; PE: premature ejaculation; PEP: Premature Ejaculation Profile; SCL‐90: Symptom Checklist‐90; SD: standard deviation; SSRI: selective serotonin reuptake inhibitor.